February 2012 Drug Update Information - Pharmacy Benefits ...

February 2012 

Drug 

Information 

Update

Drug Information 

Update 

Table of Contents 

First-Time Generics 

First-Time Generics 

New Drug Entities 

New Indications 

FDA News/Bulletins/Advisories/Safety Alerts 

Studies 

Recalls 

Current Drug Shortages 

Page 3 

Page 3-5 

Page 5 

Page 6-9 

Page 9-18 

Page 18-24 

Page 24-59 

2

GENERIC DRUG NAME 

GENERIC 

APPROVAL 

BRAND NAME 

MANUFACTU 

URER 

DATE 

EPROSARTAN 

TEVETEN 600 MG 

MYLAN 

MESYLATE 600MG 

TABLET 

12/20/11 

PNV#79/IRON/ 

NEEVO DHA 

FA/LMFOLATE 

ZERXIS PHARMA 

GELCAP 

CA/DH 

12/21/11 

FELBAMATE 

WALLACE PHARMA 

FELBATOL 600 

MG/5 ML SUSP 

12/21/11 

LAMIVUDINE/ 

ZIDOVUDINE 

TEVA USA 

COMBIVIR TABLET 12/27/11 

METHYLPHE 

ENIDATE 

HCL 

ER 20MG, 30MG, 40MG 

ACTAVIS SOUTH 

RITALIN LA 

1/4/12 

TRAMADOL HCL 100MG, 200MG, 300MG 

RHODES PHARMA / RYZOLT ER 

12/ /22/11 / 

SUN PHARMA 

TABLET 

1/3/12 

CLOBEX 

CLOBETASOL 

ACTAVIS MID ATL / 

12/ /30/11 / 

0.05% 

PROPIONATE 0.05% SHAMPOOO 

SANDOZZ 

1/4/12 

SHAMPOOO 

CLOBEX 

CLOBETASOL 

ACTAVIS MID ATL / 

0.05% 

12/ /30/11 / 

PROPIONATE 0.05% TOPICAL LOTION 

PADDOCK LABS 

TOPICAL 

LOTION 

1/3/12 

Gruenhaupt, Mark R.Ph. Argus Health Systems, Inc. c2005 Available from: www.argushealth.com [cited January 5, 2012]. 


New Drug Entities 

DESCRIPTION 

NARCOTIC 

ANTITUSS- 

1ST GEN. 

ANTIHISTAMINEDECONGEST 

BRAND 

NAME 

STATUSS GREEN 

LIQUID 

GENERIC 

NAME 

CHLORCYCLI/ 

PSEUDOEPHED/ 

CODEINE 

STRENGTH 

12.5-30-9 

NOTES 

New 

Combination 

PEDIATRIC 

VITAMIN 

PREPARATIONS 

TRI-VITAMIN 

WITH FLUORIDE 

DROPS 

PEDI MVI 

NO.21 WITH 

FLUORIDE 

0.25 MG/ 

New 

ML Combination 

CEREBRAL 

SPINAL 

RADIOACTIVE 

DIAGNOSTICS 

CERETECC IV VIAL 

KIT PREP TC- 

99M/ 

EXAMETAZIME 

0.5 MG 

New 

Entity 

SYMPATHOMIMETIC 

AGENTS 

PHENYL-EPHRINE 

HCL- NS IV PLAST. 

BAG 

PHENYLEPHRINE 

HCL/ 

NS/PF 

80MG/ 

250ML 

New 

Strength 

MULTIVITAMIN 

PREPARATIONS 

B-NEXA 

TABLET 

VIT B6/FA/ 

CALCIUM 

PHOS/ 

GINGER 

40-1.2- 

100 

New 

Combination 

PROTONPUMP 

INHIBITORS 

FIRSTOMEPRAZOLE 

SUSP RECON 

OMEPRAZOLE 

2 MG/ML 

New 

Strength 

and 

Dosage 

Form 

ADRENAL 

RADIOACTIVE 

DIAGNOSTICS 

ADREVIEW 

IV VIAL 

IOBENGUANE 

SULFATEE I-123 

10 MCI/ 

5ML 

New 

Entity 

3

RADIO 

THERA 

AGE 

DIAGN 

PREPAR 

MISCELL 

RADIO 

D 

RADIO 

O 

AUTOL 

LEUKO 

ANALG 

NARC 

ANGIO 

RECE 

ANT 

THIA 

DIUR 

CO 

ANGIO 

RECE 

ANT 

THIA 

DIUR 

CO 

GEN 

INHAL 

AGE 

PREN 

VITA 

PREPAR 

PROTO 

INHIB 

BETAADR 

BLOC 

AGE 

THIAZ 

RELA 

BETAADR 

BLOC 

AGE 

THIAZ 

RELA 

BETAADR 

BLOC 

AGE 

THIAZ 

RELA 

ACTIVE 

APEUTIC 

ENTS 

NOSTIC 

RATIONS, 

LANEOUS 

ACTIVE 

DX 

OLABEL 

OF 

LOGOUS 

OCYTES 

GESICS, 

COTICS 

OTENSIN 

EPTOR 

TAG./ 

AZIDE 

RETIC 

OMB 

OTENSIN 

EPTOR 

TAG./ 

AZIDE 

RETIC 

OMB 

ERAL 

LATION 

ENTS 

NATAL 

AMIN 

RATIONS 

ONPUMP 

BITORS 

RENERGIC 

CKING 

ENTS/ 

ZIDE & 

ATED 

RENERGIC 

CKING 

ENTS/ 

ZIDE & 

ATED 

RENERGIC 

CKING 

ENTS/ 

ZIDE & 

ATED 

SODIUM 

123 CA 

DMSA I 

INDIUM 

OXY-QU 

IV V 

HYDROM 

HCL 

PCA S 

EDARB 

TAB 

EDARB 

TAB 

HYPE 

VIAL 

CITRAN 

HARM 

CAPS 

FIR 

LANSOP 

SU 

REC 

DUTOPR 

ER 

DUTOPR 

ER 

DUTOPR 

ER 

IODIDE I- 

APSULE 

IV VIAL 

M IN-111 

UINOLINE 

VIAL 

MORPHONE 

LNS 

YRING 

BYCLOR 

BLET 

BYCLOR 

BLET 

ER-SAL 

LNEB 

NATAL 

MONY 

SULE 

RST- 

PRAZOLE 

USP 

CON 

ROL TAB 

24H 

ROL TAB 

24H 

ROL TAB 

24H 

SODIU 

IODIDE 

KIT FOR 

TC-99 

SUCCI 

INDIUM 

OXYQUIN 

HYDROMO 

HCL/ 

AZILSA 

MED/CH 

THALID 

AZILSA 

MED/CH 

THALID 

SODIU 

CHLORID 

INHALA 

PNV34/I 

CARBON 

DSS/D 

LANSOPR 

METOPR 

SUCCIN 

HCT 

METOPR 

SUCCIN 

HCT 

METOPR 

SUCCIN 

HCT 

UM 

E-123 

R PREP 

9M/ 

IMER 

IN-111 

NOLINE 

ORPHONE 

/NS 

ARTAN 

HLOR 

DONE 

ARTAN 

HLOR 

DONE 

UM 

DE FOR 

ATION 

IRON, 

NYL/FA/ 

DHA 

RAZOLE 

ROLOL 

NATE/ 

TZ 

ROLOL 

NATE/ 

TZ 

ROLOL 

NATE/ 

TZ 

3.7 MBQ 

1 MG 

1MCI/ ML 

(1) 

15 MG/ 

30ML 

40- 12.5 

MG 

40 MG- 

25MG 

3.5 % 

30-1-50 

MG 

3 MG/ML 

50-12.5 

MG 

25-12.5 

MG 

100- 

12.5MG 

Q 

N 

En 

N 

Stre 

L 

N 

Comb 

N 

Do 

Fo 

N 

Comb 

N 

Comb 

N 

Stre 

N 

Comb 

L 

N 

Stre 

a 

Do 

Fo 

N 

Comb 

N 

Comb 

N 

Comb 

4 

New 

ntity 

New 

ength 

New 

bination 

New 

osage 

orm 

New 

bination 

New 

bination 

New 

ength 

New 

bination 

New 

ength 

and 

osage 

orm 

New 

bination 

New 

bination 

New 

bination

CICLOPIROX/ 

TOPICAL 

PEDIPIROX-4 

New 

NAIL LACQ/FT 

8 % 

ANTIFUNGALS 

TOPICAL KIT 

Combination 

DEOD#4 



New Indicatio 

ons (Existing Drugs) 

Prevnar 13® 

FDA Approval to Extend Use of 

Prevnar 13® 

for Prevention of Pneumococcal Pneumonia and 

Invasive Disease in Adults 50 Years and Older 

December 30, 2011 

Pfizer Inc. announced 

that the U. .S. Food and 

Drug Administration (FDA) has granted approval 

of the Company’s pneumococcal 

conjugate vaccine Prevnar 13®* (Pneumococcal 13-valent 

Conjugate Vaccine [Diphtheria CRM197 Protein]) as a single dose for use in adults. Prevnarr 13 

is indicated for adults 50 years of 

age and older for active immunization for the prevention of 

pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae (S. 

pneumoniae) 

serotypess contained in the vaccine. 

Article link: http://www.pfizer.com/news/press_releases/ 

/pfizer_press_releases.jsp 

#guid=20120105006142en&source=RSS_2011&page=11 

Source website: http: ://www.pfizer.com 

Berinert® 

FDA Approval of Expanded Label on Berinert® for Self-administration and 

Treatment of 

Acute Laryngeal Attacks of Hereditary Angioedema 

January 

3, 2012 

CSL Behring announced that the 

U.S. Food and Drug Administrationn (FDA) has 

approved a 

label expansion for self-administration of Berinert®, C1 Esterase Inhibitor (Human), a 

pasteurized, nanofiltered therapy 

indicated for the treatment of acute 

attacks of hereditary 

angioedema (HAE), a rare and potentially fatal genetic disorder. With appropriate training from 

a physician, patients can now self-administer 

Berinert byy intravenous infusion. As part of the 

label expansion, Berinert is now also indicated to treat life-threatening laryngeall HAE attacks, as 

well as facial and abdominal attacks. 

Article link: http://www.cslbehring.com/news-room/HAE-Berinert-Self-Administration-and- 

Laryngeal-Attacks 

Source website: http: ://www.cslbehring.com/ 

FDA News/ /Bulletins/Advisories/Safety Alerts 

FDA Drug Safety Communicat 

tion: Addition of another concentration of liquid 

acetaminophen marketed for infants 

[Posted 12/22/11] 

The U.S. Food and Drug Administration (FDA) is informing the public that an additional 

concentration of liquid acetaminophen marketed for "infants" (160 mg/5 mL) is now available at 

local stores. Until now, liquid acetaminophenn marketed for infants was only available in 80 

mg/0.8 mL or 80 mg/mL concentrations. This change in the concentration will affect the amount 

5

of liquid given to an infant, and should be especially noted if someone is accustomed to using the 

80 mg /0.8 mL or 80 mg/mL concentrations 

of liquid acetaminophen. 

Article link: http://www.fda.gov/ 

/Drugs/DrugSafety/ucm284741.htm 

Source website: http: ://www.fda.gov 

FDA Alerts Pharmacists and Health Care Professionals to Potential for Injury when 

Dispensing the Similar-Sounding Drugs Durezol and Durasal 

[Posted 12/28/11] 

FDA is alerting pharmacists and other healthh care professionals of potential injury due to 

confusionn between the FDA-approved eye medicine Durezol (difluprednate ophthalmic 

emulsion) 0.05% and 

the unapproved prescription topical wart remover Durasal (salicylic acid) 

26%. There has been 

one report of serious injury when a pharmacist mistakenly gave an eyee 

surgery patient Durasal, the salicylic acid–containing wart remover, instead of the prescribed 

Durezol eye drops. Durezol is approved for treatment of inflammation and pain association with 

ocular surgery. 


/Drugs/DrugSafety/ucm285235.htm 


FDA approves shared system REMS for TIRF products 

[Posted 12/29/11] 

The U.S. Food and Drug Administration today approvedd a single shared Risk Evaluation and 

Mitigation Strategy (REMS) for the transmucosal immediate-releasee fentanyl (TIRF) products. 

This new 

shared system will replace the individual REMS and allow 

prescribers and pharmacies 

to enroll into just one 

system, easing the burden on the health care system. 


/NewsEvents/Newsroom/PressAnnouncements/ucm285345. 

htm?source=govdelivery 


Endo Pharmaceuticals Opiate Products by 

Novartis Consumer Health: Public Health 

Advisory 

[Posted 01/09/2012] 

ISSUE: FDA is advising healthcare professionals and patients of a potential problem with opiate 

products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at 

its Lincoln, Nebraskaa manufacturing site. Due to problems that occurred when these products 

were packaged and labeled at the 

site, tablets 

from one product type may have carried over into 

packaging of another 

product. This could result in a strayy pill of one medicine ending up in the 

bottle of another product. 

BACKGROUND: Opiates are potent medications used too alleviate pain and are available only by 

prescription. Endo Pharmaceuticals reports that they are aware of only three product mix-ups 

with respect to these products since 2009; alll three were detected by pharmacists. Endo is not 

aware of 

any patient having experienced a confirmed product mix-up, nor any adverse events 

attributable to a product mix-up. 

RECOMMENDATION: FDA advises patients and healthcare professionals to examine opiate 

medicines made by Endo in their 

possession and ensure that all tablets are the same. 

Article Link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ 

SafetyAlertsforHumanMedicalProducts/ucm286280.htmm 

Source website: http: ://www.fda.gov/default.htm 

Novartis 

Consumer 

Health Over-The-Counter Products: Recall - Potential Presence of 

Foreign Tablets or Chipped or Broken Tablets or Gelcaps 

6


ISSUE: Novartis Consumer Health Inc. is voluntarily recalling all lots of over-the-counter 

products Excedrin, Bufferin, Gas-X Prevention and NoDoz. Reports were received of chipped 

and broken pills and inconsistentt bottle packaging clearance practices at the Lincoln, Nebraska 

facility, which could result in the 

bottles containing foreign tablets, caplets, or capsules. 

Mixing of different products in the same bottle could result in consumers taking the incorrect 

product and receiving 

a higher or 

lower strength than intended or receiving an unintended 

ingredient. This could potentially 

result in overdose, interaction with 

other medications a 

consumer may be taking, or an allergic reaction if the consumer is allergic to the 

unintendedd 

ingredient. 

BACKGROUND: This voluntary 

recall pertains to all lots of select bottle packaging 

configurations from retailers of Excedrin and 

Nodoz products (expiry 

dates of December 20, 

2014 or earlier), and Bufferin and 

Gax-X Products (expiry dates of December 20, 2013 or 

earlier), in the United 

States. 

RECOMMENDATION: All of the pills in the bottle should look the 

same. If patients find a pill 

that is different in shape, size, color, or markings, they should bring their medicine bottle to their 

pharmacist and not take any of those pills. 




Bedford Laboratories Polymyxin B For Injection USP 

And Vecuronium Bromide For 

Injection: Recall - Glass Particles 


ISSUE: Bedford Laboratories issued guidance on the nationwide voluntary product recalls 

originally 

issued on August 2, 2011. The recalls were initiated after the discovery of a visible 

glass particle in a limited number 

of vials within the lots listed below 

to the user 

level. 

Polymyxin B for Injection USP, 500,000 Units per vial – NDC #55390-139-10 

Lot 1942980 – Exp. Date August 

2013 and Lot 1895027 – Exp. Date 

June 2013 

Vecuronium Bromide for Injection, 10 mg per vial – NDC #55390-037-10 

Lot 1865067 – Exp. Date May 2012 

Vecuronium Bromide for Injection, 20 mg per vial – NDC #55390-039-10 

Lot 1865069 – Exp. Date February 2012 

Particulate matter in injections can be harmful when introduced into the bloodstream. Potential 

adverse events after intravenous 

administration may include vein irritation and phlebitis, 

pulmonary dysfunction and granulomas, local tissue infarction, occlusion of capillaries and 

arteries, anaphylactic 

c shock, and death. The introduction 

n of particulate matter via 

the intrathecal 

route into 

the cerebrospinal fluid 

may serve as a nidus for the development of chemical 

meningitis. Introduction of a foreign body to the eye via topical or subconjuntive 

routes can 

cause corneal abrasion/laceration, lacrimal tear and general irritation. To date, there have been no 

reports of adverse events for the lots being recalled. 

BACKGROUND: Polymyxin B is indicated in the treatment of acute 

infections caused by 

susceptible strains of 

Pseudomonas aeruginosa. Vecuronium Bromide is indicated as an adjunct 

to general anesthesia, to facilitate 

endotracheal intubationn and to provide skeletal muscle 

relaxation 

during surgery or mechanical ventilation. 

RECOMMENDATION: Hospitals, emergency rooms, clinics, physician offices and other 

healthcare facilities and providers should not 

use the product lots listed above for patient care 

and should immediately quarantine any product for return. 



7


The MedWatch December 2011 Safety Labeling Changes 

[Updatedd 1/13/12] 

The following drugs had modifications to the 

BOXED WARNINGS, CONTRAINDICATIONS 

and WARNINGS sections: 

Multaq (dronedaronee hydrochloride) tablets 

Dilantin-125 (phenytoin) Oral Suspension 

Norvir (ritonavir) Soft Gel Capsules, Oral Solution and Tablets 

Relenza (zanamivir) 

inhalation powder 

Tyzeka ( telbivudine) 

tablets and oral solution 

Capoten (captopril) Tablets 

Danocrine brand of Danazol capsules 

Desferal (deferoxamine mesylate) for injection 

Edarbi (azilsartan medoxomil) Tablets 

Eloxatin (oxaliplatin) 

for intravenous use 

Heparin Sodium Injection 

Isentress (raltegravir) 

scored, chewable tablets, film-coated tablet 

Keppra ( levetiracetam) Tablets and oral solution 

Onglyza (saxagliptin) tablets 

Ovide (malathion) 0. 5% lotion1 

PegIntronn (Peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use 

Plavix (clopidogrel bisulfate) tablets 

Remeron 

(mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating 

Zegerid (omeprazole 

e/sodium bicarbonate) powder for oral suspension and capsules 


/Safety/MedWatch/SafetyInformation/Safety- 

RelatedDrugLabelingChanges/ucm284231.htm?source=govdelivery 


Adcetris 

(brentuximab vedotin): Drug Safety Communication - Progressivee Multifocal 

Leukoencephalopathy and Pulmonary Toxicity 


ISSUE: FDA notified 

healthcare professionals that two additional cases of progressive multifocal 

leukoencephalopathy 

(PML), a rare but serious brain infection that can result in death, have been 

reported with the lymphoma drug 

Adcetris (brentuximabb vedotin). Due to the serious nature of 

PML, a new Boxed Warning highlighting this risk has been added to 

the drug label. 

In addition, a new Contraindication warning was added against use of Adcetris with the cancer 

drug bleomycin due to increased risk of pulmonary (lung) toxicity. 

The signs and symptoms of PML 

may develop over the course of several weeks or months. They 

may include changes 

in mood or usual behavior, confusion, thinking 

problems, loss of memory, 

changes in vision, speech, or walking, and decreased strength or weakness on one side of the 

body. 

BACKGROUND: Adcetris (brentuximab vedotin) is used to treat Hodgkin lymphoma and a rare 

lymphoma known as systemic anaplastic large cell lymphoma. At the time of Adcetris' approval 

in August 2011, one case of PML 

was described in the Warnings and 

Precautions section of 

the 

label. 

RECOMMENDATION: Patients 

who develop any signss and symptoms of PML 

should notify 

their healthcare professional immediately. Healthcare professionals should hold Adcetris dosing 

if PML is 

suspected and discontinue Adcetris 

if a diagnosis of PML is confirmed. See the Data 

Summary 

in the Drug 

Safety Communicationn for additional information. 

8

Studies 




Tysabri (natalizumab): Drug Safety Communication 

- New Risk 

Factor for Progressivee 

Multifocal Leukoencephalopathy (PML) 


ISSUE: FDA notified 

healthcare profesisonals that testing positive for anti-JC virus (JCV) 

antibodies has been identified as a risk factor 

for progressive multifocal leukoencephalopathy 

(PML). PML is a rare 

but seriouss brain infection associated with use 

of Tysabri (natalizumab) for 

the treatment of multiple sclerosis (MS) or Crohn's disease. 

A patient's anti-JCV antibody status may be determined using an anti-JCV antibody detection 

test that has been analytically and 

clinically validated, and has been ordered by a healthcare 

professional. The Stratify JCV Antibody ELISA test2 was cleared by 

FDA on January 20, 2012. 

Testing positive for anti-JCV antibodies means that a person has been exposed to 

JCV in the 

past. 

BACKGROUND: Tysabri (natalizumab) is in a class of medicationss called immunomodulators. 

It works by stopping certain cells 

of the immune system from causing damage to 

the body. 

Tysabri is approved for the treatment of relapsing forms of multiple sclerosis since November 

2004 and 

for the treatment of moderately to severely active Crohn's disease since 

January 2008. 

RECOMMENDATION: The risks and benefits of continuing treatment with Tysabri should be 

carefully 

considered in patients who are found to be anti-JCV antibody positive and have one or 

more of the other known risk factors for PML. Patients with all threee known risk 

factors have an 

estimated 

risk of PML of 11/1,000 users. 




Drug Coatings Can Contain Problematic Chemicals 


Potentially harmful chemicals show up in a wide variety of drugs and 

supplements, especially 

ones with 

time-release coatings. A large number of common drugs and supplements contain 

chemicals called phthalates, which are often found in plastics, found 

a new study. These 

chemicals have been linked to a variety of hormonal andd reproductive problems in both rats and 

people. 

Article link: http://news.discovery.com/human/pill-coatings-chemicals-hormones-111222.html 

Source website: http: ://news.discovery.com/ 

Bristol-Myers Says Liver Cancer Drug Didn’t Meet Goals in Trial 


Bristol-Myers Squibbb Co. said its experimental brivanib drug for liver cancer didn’t improve 

patient survival better than a placebo. The study, one of four final-stage clinical trials evaluating 

brivanib in liver cancer, tested the experimental drug in patients who 

failed on or 

were intolerant 

to Nexavar, the liver cancer drug 

from Onyx Pharmaceuticals Inc. and Bayer AG, Bristol said 

today in a statement. New York-based Bristol will continue with the other trials, it said. 

Article link: http://www.bloomberg.com/news/2011-12-22/bristol-myers-says-liver-cancer- 

drugdidn-t-meet-goals-in-trial.html 

9

Source website: http: ://www.bloomberg.com/ 

Painkiller 10 times stronger than Vicodin worries addiction experts 


As pharmaceutical companies are 

approaching the final stages of development for a new type of 

painkiller 

said to be 10 times stronger than Vicodin, addiction experts worry a new wave of 

abuse may soon follow. Four companies have begun patient testing on the pills which contain a 

pure version of the highly addictive painkiller hydrocodone, and one 

of them - Zogenix of San 

Diego - plans to apply early next 

year to begin marketingg its product, Zohydro. 

Article link: http://www.cbsnews.com/8301-504763_162-57348477-10391704/painkiller-10- 

timesstronger-than-vicodin-worries-addiction-experts/ 

Source website: http: ://www.cbsnews.com/ 

Adding Lovenox Didn't Reducee Blood Clot Death Risk in Study 


Severely ill hospital patients are at high risk for developing potentially fatal blood clots, and 

often wear compression stockings and/or take blood thinners to help lower this risk. However, 

adding the blood thinner Lovenox (enoxaparin) to the mix does not reduce their chances of dying 

from a blood clot, according to research appearing in thee Dec. 29 issue of the New England 

Journal of Medicine. 

Article link: http://news.yahoo.com/ adding-lovenox-didnt-reduce-blood-clot-death-risk- 

220408913.html 

Source website: http: ://news.yahoo.com/ 

Avastin disappointss against ovarian cancer 


Avastin, the blockbuster drug that just lost approval for treating breast cancer, now looks 

disappointing against 

ovarian cancer, too. Two studies found it did not improve survival for most 

of these patients and kept their disease from worsening for only a few 

months, with more side 

effects. 

Article link: http://www.businessweek.com/ap/financialnews/D9RTQ2081.htm 

Source website: http: ://www.businessweek.com/ 

FDA warns docs on 

wart remover and eyee salve mix-ups 


The U.S. Food and Drug Administration warned healthcare workers on Wednesday to be careful 

when using two similarly named but very different drugs, saying a recent mix-up 

involving the 

two medications had injured a patient. The agency said the incident occurred when a pharmacist 

confused 

Durasal, a wart remover not approved by the FDA, with Durezol, an FDA-approved 

steroidal eyedrop used to treat inflammation 

and pain following eye surgery. 

Article link: http://www.courant. 

.com/health/sns-rt-us-drug-name-mixuptre7br12w- 

20111228,0,5878740.story 

Source website: http: ://www.courant.com/ 

Janssen Research & Development Submits Application to U.S. FDA for XARELTO 

(rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute 

Coronary Syndrome 


Janssen Research & Developmen 

nt announced 

today that it has submitted a supplemental New 

Drug Application (sNDA) to the U.S.Food and Drug Administrationn (FDA) seeking approval for 

10

the use of XARELTO® (rivaroxaban), an oral anticoagulant, to reduce the risk of (thrombotic) 

cardiovascular events in patients with Acute Coronary Syndrome (ACS). 

Article link: http://www.pharmalive.com/News/index.cfm?articleid= 

=819584 

Source website: http: ://www.pharmalive.com/ 

F.D.A. Finds Short Supply of Attention Deficit Drugss 


Medicines to treat attention deficit hyperactivity disorderr are in such 

short supply 

that hundreds 

of patients complain daily to the Food and Drug Administration that they are unable to find a 

pharmacy 

with enough pills to fill their prescriptions. The shortages are a result of a troubled 

partnership between drug manufacturers and the Drug Enforcement Administration, with 

companies trying to maximize their profits and drug enforcement agents trying to minimize 

abuse by people, many of them college students, who usee the medications to get high or to stay 

up all night. 

Article link: http://www.nytimes.com/2012/01/01/health/policy/fda-is-finding-attention-drugs- 

for 

inshort-supply.html? 

_r=2 

Source website: http: ://www.nytimes.com/ 

ADHD drugs do not 

increase risk of heart 

disease in adults, study finds 

January 2, 2012 

ADHD drugs raise blood pressure but do not 

seem to endanger adultt hearts. 

THE QUESTION Might adults with attentionn deficit/hyperactivity disorder face added risk serious cardiovascular problems because of the medications they take — drugs that have been 

shown to 

raise blood 

pressure and heart rate? 

THIS STUDY analyzed data on 443,198 adults, 25 to 644 years old, including 150,359 who took 

ADHD medications, 

mainly Ritalin (methylphenidate) orr Adderall (amphetamine) but also 

Strattera (atomoxetine) or Cylert 

(pemoline). 

In about a two-year period, 1,357 heart attacks, 575 

strokes and 296 sudden cardiac deaths were recorded. However, the cardiovascular problems 

occurred at virtually the same rate among people who took ADHD medications and those who 

did not, regardless of 

people’s age, how long 

they had been taking the medication or which drug 

they took. 

Article link: http://www.washingtonpost.com/national/health-science/adhd-drugs-do-not- 

Source website: http: ://www.washingtonpost.com/national 

Giving Antidepress 

ants a Boost With a Vitamin 


increaserisk-of-heart-disease-in-adults-study-finds/2011/ 

/12/23/gIQAhLeoWP_story.html 

Deplin, a Prescription 

Form of Folate, Is Increasingly Used for Patients With Resistant Cases of 

Depression. Could a vitamin make antidepressants work better? That's the tantalizing premise 

behind Deplin, a prescription form of the B-vitamin folate. Althoughh it has been on the market 

since 2006, Deplin is 

generating growing buzz at psychiatric conferences and among clinicians 

and patients, particularly those who haven't responded too antidepressants or did for a while only 

to have their depression return. 

Article link: http://online.wsj.com/article/SB10001424052970204368104577136850522166664. 

html# 

Source website:http: 

//online.wsj.com/home-page 

of Expanded Label on Berinert for 

CSL Behring Receives FDA Approval 

Selfadministration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema 


11

Patients with rare, sometimes life-threatening 

condition can now treat themselves at home at 

the 

first sign of acute facial, abdominal or laryngeal swellingg attacks. CSL Behring today announced 

that the U.S. Food and Drug Administration 

(FDA) has approved a label expansion for self- 

therapy 

indicatedd for the treatment of acute attacks of 

hereditary angioedemaa (HAE), a rare and 

administration of Berinert ®, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered 

potentially fatal genetic disorder. 

With appropriate training from a physician, patients can now 

self-administer Berinert by intravenous infusion. As partt of the labell expansion, Berinert is now 

also indicated to treat life-threatening laryngeal HAE attacks, as well as facial and abdominal 

attacks. 

Article link: http://www.pharmalive.com/News/index.cfm?articleid= 

=819777 

Source website: http: ://www.pharmalive.com/ 

Arena says addressed FDA concerns on weight loss drug 


Arena Pharmaceuticals Inc said on Tuesday it submitted data to health regulators 

that 

should squash cancer 

concerns tied to the company's experimental weight loss drug lorcaserin, 

and believes it will gain U.S. approval. 

Article link: http://www.reuters.com/article/2012/01/03/us-arena- 

you thousands, prevent 

hospital stays 

obesityidUSTRE8021VJ20120103 

Source website http:/ //www.reuters.com 

Following the doctor's orders on your medicine can save 


Not taking your medicines as prescribed can hurt your wallet as welll as your health and far 

outweigh 

any savings on your pharmacy bill. Not filling prescriptions and even skipping doses 

can result in serious complication 

ns and lead to ER visits and hospitall stays, even 

premature 

death. 

Article link: http://www.chicagotribune.com/ 

/business/sns-ap-us-money--health-taking- 

yourmeds,0,4075199.story 

Source website: http: ://www.chicagotribune.com/business/ 

Cancer rates in U.S. keep falling: report 


Cancer death rates are continuing 

to fall, dropping by 1.88 percent perr year in men 

and 1.6 percent 

per year in women between 2004 

and 2008, according too the American Cancer Society's annual 

report on 

cancer statistics released on Wednesday. Advances in cancer screening 

and treatment 

have prevented more 

than a million total deaths from cancer since the early 1990s, according 

to 

the report. But the influential cancer group said new cases of seven less-common 

cancers rose in 

the past decade, suggesting more 

could be done in America's 40-yearr war on cancer. This year, 

the cancer group projects 1,638,910 people will be newlyy diagnosed with cancer 

and 577,190 

people will die from it. 

Article link: http://www.reuters.com/article/2012/01/04/us-usa-cancer-rates- 

idUSTRE8032A420120104 

Source website: http: ://www.reuters.com 

FDA restricts class of antibiotics in animals 


Health regulators placed restrictions on animal use of a class of antibiotics often used to treat 

diseases like pneumonia in humans, as part of an effort too prevent the 

rise of drug-resistant 

12

acteria. The Food and Drug Administration 

issued an order on Wednesday to stop the 

widespread injection of cephalosporins into cattle, pigs, chickens and 

turkeys beginning April 5. 

Cephalosporins are commonly used to treat people with pneumonia and skin and 

soft tissue 

infections, the FDA said. They can also be used to treat foodborne illnesses such 

as salmonella 

and E. coli. 

Article link: http://www.reuters.com/article/2012/01/04/us-fda-antibiotics- 

promising 

results in an 

idUSTRE80329V20120104 


Achillion's hepatitis 

C drug gets FDA fast track 


A new vaccine against the chronic liver disease hepatitis C has shown 

early-stage clinical trial in humans, British and Italian scientists said 

Wednesday. They said the 

experimental vaccine, which is based on a modified coldd virus and was safety-tested in 41 

people, generated immune responses similar to those seen in people who have a rare but 

natural defense against the disease. 

Article link: http://www.reuters.com/article/2012/01/04/us-hepatitis-c-vaccine- 

that combining anti-HIV 

and anti- 

idUSTRE8031QW20120104 


Guideline Urges Care in Mixing HIV, Seizure Drugs 


Althoughh the evidence is weak, doctors should be aware 

epileptic medications 

may lead to 

drug-on-drug interactions, according to a new guideline. 

The issue 

is growing in importance as more and more people -- especially in the developing 

world -- are living with HIV as a chronic disease. And upp to 55% of people taking antiretroviral 

medications may need epilepsy control drugs 

at some point, althoughh not for seizures in every 

case. 

Article link: http://www.medpagetoday.com/ 

/Neurology/ Seizures/30489 

Source website http:/ //www.medpagetoday.com 

J&J Halts Study of Doribax Antibiotic on Higher Death Rate 

Jan 5, 2012 

Johnson & Johnson halted a clinical trial of its antibiotic Doribax after more pneumonia 

patients who took the 

product died and fewer 

were cured, regulators said. Doribax, already 

approved 

for urinary and abdominal infections in the U.S., is still considered safe and effective 

for those uses, the Food and Drug 

Administration said today in a statement on its 

website. The 

trial tested the drug in 

pneumonia 

patients who were on ventilators, an indicationn for 

which it’ s approved in Europe. 

Article link: http://www.bloomberg.com/news/2012-01-05/j-j-halts-study-of-doribax-antibiotic- 

a 

onhigher-death-rate.html 


Drug Eases Gout Flare-ups in Some Patients: Study 


Starting gout treatment can lead to flare-ups, this drug might help. Preliminary findings suggest 

drug used 

to treat another diseasee might also reduce painful flareups in gout patients starting 

new 

medication regimens. In a new study, the protein-inhibitor drug rilonacept (Arcalyst) appeared to 

markedly 

lower the risk of gout flare-ups during the firstt few monthss of treatments aimed at 

lowering 

uric acid levels. 

13

Article link: http://health.usnews.com/health-news/family- 

health/pain/articles/2012/01/05/drugeases-gout-flare-ups-in-some-patients-study 

Source website: http: ://www.usnews.com/ 

ADHD Drug Shortage Pushes Parents to Seek Substitutes 


But experts say medication switches must be 

done carefully. If the current shortage of some 

drugs used to treat attention-deficit/hyperactivity disorder (ADHD) has left you searching for 

something else for your child to take, experts 

suggest youu choose a substitute carefully because 

the effects of these medications can vary widely. 

Article link: http://consumer.healthday.com/Article.asp?AID=660423 

Source website: http: ://consumer. healthday.com/ 

Boehringer’s Pradaxa Increases Risk of Heart Attack, Study Shows 


Boehringer Ingelheim’s anti-coagulant Pradaxa increasess a patient’s risk of heart 

attack or severe 

chest pain, according 

to a review 

of studies conducted onn the drug. An analysis of seven clinical 

trials found that it was “significantly associated with a higher risk” of heart attacks and acute 

coronary 

syndrome, or ACS, a designation that includes heart attacks and chest pain, researchers 

wrote in a report published today 

in the Archives of Internal Medicine. 

Article link: http://www.bloomberg.com/news/2012-01-09/boehringer-s-pradaxa-increases-risk- 

some investors on Monday. 

Article link: http://uk.reuters.com/article/2012/01/09/uk-gsk-relovair- 

idUKTRE8080C120120109 

Source website: http: ://uk.reuters.com/ 

Nicotine 

Gum and Skin Patch Face New Doubt 


ofheart-attack-study-shows.html 

website: http: ://www.bloomberg.com/ 

Aspirin guidelines need overhaul, researchers say 

Source 


Healthy people shouldn't be taking aspirin to 

prevent heart disease, researchers say in a new 

report that casts doubt on recommendations from U.S. health officials. 

Article link: http://www.reuters.com/article/2012/01/09/us-aspirin- 

benefitsidUSTRE80825720120109 

Source website: http: ://www.reuters.com/ 

GSK to file lung drug despite disappointin 

ng data 


GlaxoSmithKline will push ahead with filing 

its key new 

lung drug Relovair for regulatory 

approval in mid-2012, despite releasing a mixed batch off clinical trial results that disappointed 

The nicotine gum and 

patches that millions of smokers use to help kick their habit have no 

lasting benefit and may backfire in some cases, accordingg to the most rigorous long-term study to 

date of so-called nicotine replacement therapy. 

Article link: http://www.nytimes.com/2012/01/10/health/study-finds-nicotine-gum-and- 

patchesdont-help-smokers-quit.html 


14

Statins raise risk of 

Type 2 diabetes in older women, study finds 


Post-menopausal women who take statins to ward off heart attacks are more likely to develop 

Type 2 diabetes than those who do not, research indicates. Older women who take statin 

medications to ward off heart attacks are more likely to develop Type 2 diabetes 

than those who 

do not take the widely used cholesterol-lowering drugs, a study has found. 

Article link: http://www.latimes. 

com/news/science/la-he-statins-diabetes-20120110,0,1285531. 

story?track=rss 

Source website: http: ://www.latimes.com/ 

Roche’s Zelboraf for Melanoma Spurs Other Skin Cancer’s Growth, Study 

Says 


Roche’s melanoma drug Zelboraf speeds growth of another type of skin cancer, researchers said 

today in a study underscoring the 

need to testt the medicine in combination with a second 

treatment. Scientists at the Institute of Cancer Research analyzed DNA in 21 tissue samples from 

Zelboraf 

patients who developedd cutaneous squamous-ce 

ell carcinoma. About 60 percent of the 

samples had one of two known cancer-causing gene mutations not targeted by the drug, they 

said 

in an article published in the New 

England Journal of Medicine today. 

Article link: http://www.bloomberg.com/news/2012-01-18/roche-s-zelboraf-for-melanoma- 

spursother-skin-cancer-s-growth-study-says.html 


Antidepressants While Pregnant Linked to 

Slight Risk of Lung Problem in Babies 

Jan 12, 2012 

Study found women who took SSRIs a bit more likely too have infants with high blood pressure 

in the lungs. Women 

who use antidepressants called selective serotonin-reuptakee inhibitors such 

asProzac and Celexa during pregnancy run a slight risk of having an infant with high blood 

pressure in the lungs, a new Swedish study finds. 



DNA Damage From 

Chemo May Help Spur Leukemia's Return 

Jan. 12, 2012 

The treatment can achieve acute myeloid leukemia remission, but better options needed, experts 

Say. The chemotherapy used to treat a form of adult leukemia sets a trap that can 

result in the 

return of 

the disease within years, a new study suggests. 



Diabetes 

Drug Helps All Shed Pounds 


One class of diabetes 

drugs -- the 

glucagon-like peptide-researchers found. 

receptor (GLP-1) agonists -- can help 

diabetics and nondiabetics alike lose weight, 

Article link: http://www.medpagetoday.com/ 

/PrimaryCare/Diabetes/30638 

Source website: http: ://www.medpagetoday.com/ 

Antidepressant Use Linked to Increased Pulmonary Hypertension Risk in Infants 


A study published in the British Medical Journal this week provides stronger evidence that 

taking some antidepressants during pregnancy doubles the risk of a baby developing pulmonary 

15

hypertension. Researchers have long suspected a link between the use of selective serotonin 

reuptake inhibitors, or SSRIs, and the condition, but previous studiess have been small and 

inconclusive (with results ranging from theree being no link to a six times greaterr risk). 

Article link: http://parenting.blogs.nytimes.com/2012/01/13/antidepressant-use-linked- 

toincreased-pulmonary-hypertension-risk-in-infants/ 

CDC Warns Against Sharing Insulin Pens 



Due to a growing number of reports about improper use of insulin pens, the U.S. . Centers for 

Disease Control and Prevention has issued a reminder that the devices must never be used on 

more than one person. Using insulin pens on more than one person puts people at risk for 

infectionn with blood-bornwarns. Infection can occur even if an 

insulin pen' 's needle is changed. 

pathogens such as hepatitis viruses and HIV, which causes AIDS, the 

agency 

Article link: http://news.yahoo.com/cdc-warns-against-sharing-insulin-pens-190308004.html 

Source website: http: ://news.yahoo.com/ 

Drug Shortages Raise Risk of Cancer Counterfeits, U.S. Says 


Shortages of some injectable cancer drugs have created an opening for dangerous unapproved 

versions of Roche’s Herceptin and Amgen’s Neupogen to be sold to clinics and other health-care 

providers, the U.S. said. The Food and Drug Administration issued a notice today warning 

providers 

to avoid direct solicitations from unproven sources and only buy drugs 

through 

approved 

channels. 

Article link: http://www.bloomberg.com/news/2012-01-13/drug-shortages-raise-the-risk- 

risk. Some pediatricians 

continue to do electrocardiograms (EKGs) on 

children before starting them on medication for 

attention-deficit hyperactivity disorder, new research suggests, even though many experts say the 

ofcounterfeit-cancer-medicines-u-s-says.html 

website: http: ://www.bloomberg.com/ 

Pediatricians Split on Heart Tests Before Kids 


Source 

About 15 

percent order EKGs; recent studiess say drugs don't pose heart 

latest evidence shows it isn't really necessary. 



Glaxo, Roche Breast-Cancer Treatments Work Better Combined, Study Shows 


Combining GlaxoSmithKline’s Tykerb drug with Roche’s Herceptin 

to treat breast cancer was 

almost twice as effective as single-drug therapy, according to researchers in a 23-country clinical 

trial. 

Article link: http://www.bloomberg.com/news/2012-01-17/glaxo-roche-breast-cancer- 

treatmentswork-better-combined-study-shows.html 


Study Disputes Finding That Hormone Therapy Causes Breast Cancer 


16

The Million Women Study, a U.K. project that found hormone replacement therapy led to 

increased 

risk of breast cancer, had flaws that call into question the findings, according to a 

review of 

the evidence led by a South African researcher. 

Article link: http://www.bloomberg.com/news/2012-01-16/study-disputes-finding-that- 

take 

hormonetherapy-causes-breast-cancer.html 


New 'smart' pill tells patients when drugs dose due 


A new "intelligent" pill that tells patients how 

to better follow doctors’ orders and 

medication properly is to go on sale in Britain within months, it has been announced. 

Article link: http://www.telegraph.co.uk/health/healthnews/9019651/New-smart-pill-tells- 

study 

patientswhen-drugs-dose-due.html 

Source website: http: ://www.telegraph.co.uk/ 

Antidepressants Might Raise Fall Risk in Nursing Homes 


Residents with dementia taking so-called SSRIs seem to be at higherr risk of injury, 

suggests Antidepressants called selective serotonin reuptake inhibitors (SSRIs) are associated 

with an increased risk 

of falls in nursing home residents with dementia, a new study finds. 



Bristol, AstraZenec 

ca Diabetes Drug Fails to Win FDA 

Backing 


Bristol-Myers Squibbb Co. and AstraZeneca Plc failed to win U.S. clearance to sell the first in 

a 

new class of experimental diabetes pills as regulators sought more data on the medicine’s safety. 

The Food 

and Drug Administrati 

ion is seeking data from ongoing studies of the treatment, 

dapagliflozin, in adults with Type 2 diabetes and may require new clinical trials to better assess 

the risks and benefits, the companies said today in a statement. Bristol-Myers, based in New 

York, and London-based AstraZeneca remain 

committedd to the drug, they said. 

Article link: http://www.businessweek.com/news/2012-01-19/bristol-astrazeneca-diabetes- 

drugfails-to-win-fda-backing.html 

website: http: ://www.businessweek.com/ 

Source Recalls 

PRODUCT (CLASSS I) 

Virility Max, 10 Capsules, Supplement Facts 

Serving Size 1 Capsule, Keep away 

from children, 

For mens 

use only, Contains 450 

mg, Rowdy 

Lamb, Puncture vine, Ginnsue Herb, Aarons Rod, 

Matrimony Vine, Cocky Cinnamon. Recall # D-1184-2012 

CODE 

Lot #: 10090571 

RECALLING FIRM/MANUFACTURERR 

Recalling 

Firm: Keime, Inc., Boca Raton, FL, by press release on November 11, 

2011. 

Manufacturer: ABCO 

Laboratories, Inc., Fairfield, CA. Firm initiated recall is ongoing. 

REASON 

Marketed 

Without an 

Approved NDA/ANDA 

A: Product found to contain sulfoaildenafil and 

sulfosildenafil, analogues of sildenafil, the active ingredient in a FDA 

approved drug used to 

treat erectile dysfunction, making 

Virility Max an unapproved new drug. 

17

PRODUCT (CLASSS II) 

1) LO/OVRAL-28 (norgestrel and ethinyl estradiol tablets), 21 white 

tablets each 

containing 

0.3 

mg norgestrel with 0.03 mg ethinyl estradiol, and 7 pink inert tablets, Package contains 6 Pilpak 

Dispensers of 28 Tablets each, Rx Only, NDC 24090-801-84. Recalll # D-1188-2012; 

2) Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg Tablets --- 21 white tablets, each 

containing 

0.3 

mg norgestrel with 0.03 mg ethinyl estradiol, and 7 pink inert tablets, Package contains 6 Pilpak 

Dispensers of 28 Tablets each, Rx Only, NDC 24090-961-84. Recalll # D-1189-2012 

CODE 

1) Lot Expiration; E15678 08/31/2013; E15679 08/31/2013; E156866 08/31/2013; E15687 

01/31/2014; E15690 01/31/2014; E15698 01/31/2014; E15700 02/28/2014; E80434 07/31/2013; 

E80438 08/31/2013; 

F36908 02/28/2014; F36909 02/28/ /2014; F43915 03/31/2014; F43926 

03/31/2014; F43927 03/31/2014; 

2) Lot Expiration; E15677 08/31/2013; E15704 01/31/2014; E15706 

01/31/2014; E80440 

08/31/2013; F16388 01/31/2014; 

F16390 02/ /28/2014; F22132 02/28/2014; F31330 02/28/2014; 

F36911 03/31/2014; 

F36913 03/31/2014; F43924 03/31/ /2014; F43925 03/31/2014; F43934 

03/31/2014; F53238 03/31/2014 


Recalling 

Firm: Pfizer Inc., New 

York, NY, by press release issued on February 1, 2012. 

Manufacturer: Pfizer, Inc., Rouses Point, NY. Firm Initiated recall iss ongoing. 

REASON 

Contraceptive Tablets Out of Sequence: some blister packs may contain an inexact count of inert 

or active ingredient tablets and that the tablets may be out of sequence. 

PRODUCT (CLAS II) 

1) 15% Minoxidil for 

Men, Enhanced with Azelaic 5%, Topical Hairr Regrowth Formula, 2 fl oz 

60 mL bottles. Recall # D-1190-2012; 


Men, Enhanced with Azelaic 5%, Topical Hairr Re-growth 

Formula, 2 fl oz 

60 mL glass bottle. Recall # D-1191-2012; 

3) 5% Minoxidil for Men, Enhanced with Azelaic 5% Topical Hair Regrowth Formula, 2 fl oz 60 

mL glasss bottle. Recall # D-1192-2012; 


Women, Enhances with 

Azelaic 1.5%; Hair Regrowth Topical, 2 fl oz 60 

mL glasss bottles, Recall # D-1193-2012; 

5) Hair Regrowth Shampoo Enhanced with Ketoconazol 

le and Salicylic Acid, 6 fl oz. 180 mL, 

plastic bottle, Recall # D-1194-2012 

CODE 

1) All expiration dates up to Oct. 

2013; 

2) All expiration dates up to Oct. 

2013; 

3) All expiration dates up to Sept. 2014; 

4) All expiration dates up to Nov. 2013; 

5) All expiration dates up to Dec. 2013. 


Recalling 

Firm: Perfect Image Solutions LLC, Roseville, CA, by press on January 19, 2012 and 

letters on 

January 20, 2012. 

Manufacturer: Custom Manufacturing Corp, Medley, FL. Firm initiated recall is ongoing. 

REASON 

Marketed 

Without an 

Approved NDA/ANDA 

A: products are unapproved drugs. 


18

Azithromycin 250 mg tablets, 1 card x 6 Tablets, Rx only, NDC 0093-7146-18 (Teva 

Pharmaceuticals), A-S Product No. 5755-0. Recall # D-1198-2012 

CODE 

Lot 1318262, Exp 04/14 


Recalling 

Firm: A-S Medication Solutions LLC, Libertyville, IL, by letters datedd January 24, 

2012 and 

telephone. 

Manufacturer: Teva Pharmaceuti 

ical Industries, Jerusalem, Israel. Firm initiated recall is ongoing 

REASON 

Labeling: Label with 

Incorrect Expiration Date. 


1) TestaEdge Cream For Men, Homeopathic 

, packaged in 4-oz. jars, Paraben Free, NDC # 

57520-0688-1, UPC Code 898849001001. Recall # D-1199-2012; 

2) TestaEdge Cream For Women, Homeopathic, packaged in 4-oz. jars, Paraben 

Free, NDC # 

57520-0907-1, UPC Code 898849001018. Recall # D-1200-2012; 

3) Pain Relief Cream, Homeopathic, packaged in 4-oz jars, Paraben Free, NDC # 57520-0689-1, 

UPC Code 898849001025. Recall # D-1201-2012; 

4) Libido 

Edge Labs Total GH Cream, Homeopathic, packaged in 4-oz. jars, Paraben free, NDC 

# 57520-0690-1, UPC 

Code 898849001278. 

Recall # D-1202-2012 

CODE 

1) Lot G7519; 

2) Lot G7518; 

3) Lot G7437; 

4) Lot G7438 


Apotheca 

Inc, Woodbine, IA, by telephone on January 17, 2011 and e-mail and certified mail 

letters on 

January 20, 2011. Firm 

initiated recall is ongoing. 

REASON 

Microbial Contamination of Non-Sterile Products: presence of Enterobacter gergoviae and 

Pseudomonas monteilii/plecoglossicida. 


Medroxyprogesterone Acetate Injectable Suspension, USP 150 mg/mL, a) 1mL Vials (NDC 

0703-6801-01); b) box of 25 single dose vials (NDC 0703-6801-04); 

; and c) 1mL 

Prefilled 

Syringes (NDC 0703-6811-21), Rx only, For 

IM Use Only. Recall # D-1180-2012 

CODE 

a) Lot #’ s: 31310301B, exp 12/2011; 31310788B, exp 1/ /2012; 31311008B, exp 4/2012; b) Lot 

#’s: 31310787B, exp 

1/2012; 31311357B, exp 4/2012 and c) Lot #’s: 31311217B, exp 2/2012; 

31311219B, exp 2/2012; 31312156B, exp 4/2012; 31312300B, 4/2012 

RECALLING FIRM/MANUFACTURE 

Recalling 

Firm: Teva 

Pharmaceuticals USA, Inc., Sellersville, PA, by letter on December 1, 

2011. 

Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. Firm initiated ongoing. 

REASON 

Presence of Particulate Matter; presence of silicone particles. 


Amlodipine Tablets USP, 2.5 mg, Once-Daily, Qty 30 tablets per Unit Carton, Rx Only, NDC 

76237-109-30. Recall # D-1181-2012 

19

CODE 

Lot #: 0000000, Exp 00/00/0000 


Recalling 

Firm: McKesson Packaging Services, Concord, NC, by letter on /about January 10, 

2012. 

Manufacturer: Omnicare Inc., Covington, KY. Firm initiated recall is ongoing. 

REASON 

Unit Dose Mispackaging; cartons labeled as Amlodipinee Tablets, NDC 76237-109-30 actually 

contain blister 


Alprazolam Tablets, USP, 2 mg, Rx only, a) NDC 0603-2130-21 (100-count bottle), b) NDC 

0603-2130-28 (500-count bottle) ). Recall # D-1185-2012 

CODE 

a) Lot #: T025D10A, exp. 06/12; 

T026D10A, exp. 06/12; T023D10B, exp. 04/12; T024D10B, 

exp. 04/12; T182H10A, exp. 09/ 12; T185H10A, exp. 10/ /12; T020J10A, exp. 10/ /12; T021J10A, 

exp. 10/12; T003L10A, exp. 12/12; T178M10A, exp. 01/13; T179M10A, exp. 01/13; 

T202B11A, exp. 02/ 13; T239C11A, exp. 02/ /13; T025D11A, exp. 03/13; T024D11A, exp. 03/13; 

T026D11A, exp. 04/ 13; T027D11A, exp. 04/ /13; T019E11A, exp. 04/13; T020E11A, exp. 04/13; 

T021E11A, exp. 04/13; T021H11A, exp. 07/ /13; T017J11A, exp. 08/ /13; T016J11A, exp. 08/ /13; 

T020K11A, exp. 09/ 13; b) Lot #: T148M09A, exp. 12/11; T164M09A, exp. 12/11; T022D10A, 

exp. 04/12; T023D10A, exp. 04/ 12; T024D10A, exp. 04/ /12; T026D108B, exp. 06/12; 

T183H10B, exp. 10/ 12; T184H10A, exp. 10/ /12; T186H10A, exp. 10/12; T187H10A, exp. 10/12; 

T180M10A, exp. 01/ /13; T076B11A, exp. 02/13; T201B11A, exp. 02/13; T240C11A, exp. 02/13; 

T028D11A, exp. 04/ 13; T029D11A, exp. 03/ /13; T017E11A, exp. 05/13; T018E11A, exp. 03/13; 

T022H11A, exp. 07/ 13; T018J11A, exp. 08/ 13; T019K11A, exp. 09/ /13 


Vintage Pharmaceuti 

icals LLC dba Qualitest Pharmaceuticals, Huntsville, AL, by 

letters on 

December 30, 2011. 

REASON 

Tablet Separation: Premature tablet breakage. 


CARDURA XL (doxazosin mesylate extended release tablets) 4 mg, , 30 ct bottle, NDC 0049- 

2710-30, 

Recall # D-1186-2012 

CODE 

Lot V101161, Exp. 04/12 

RECALLING FIRM/MANUFACTURER 

Pfizer US 

Pharmaceutical Group, New York, NY, by letter on January 11, 2012. 

Firm initiated 

recall is ongoing. 

REASON 

Failed USP Dissolution Test Requirements: Stability testing yielded an out of specification result 

for an individual value at 8 hour dissolution. 


Acetaminophen and Codeine Phosphate CIIII Tablets USP 300 mg/60 

mg, (Each tablet contains: 

Acetaminophen USP...300 mg and Codeine Phosphate USP...60 mg) ), 100 count bottles, Rx 

Only, NDC 0406-0485-01. Recall # D-1183-2012 

CODE 

Lot number: 0485T81671, Expiration date: 10/2013 

20


Recalling 

Firm: Mallinckrodt Inc., Hazelwood, MO, by letters on January 11, 2012. 

Manufacturer: Mallinckrodt Inc., 

Hobart, NY. Firm initiated recall iss ongoing. 

REASON 

Labeling: Incorrect or Missing Package Insert. 


Equate Fiber Therapy, Sugar Free, Orange Flavor, 36.8 oz., packaged in plastic bottles, NDC 


CODE 

Codes: H16601X, H16602X, H16603X, H16604X, H16605X, H16606X, H16607X, H16608X, 

H16609X, H16610X, H16611X, H16612X, H16613X. All Exp. Date 

08/2013 


Konsyl Pharmaceutic 

cals Inc., Easton, MD, by 

letter on October 26, 2011. Firm initiated recall is 

ongoing. 

REASON 

Labeling: Label lacks Warning; Warning advisory regarding phenylketonurics in 

the product is 

not stated 

on the label. 


Fluoxetine Capsules USP 10 mg, 

Rx only, 1000 Capsules, NDC 0781-2823-10. 

Recall # D- 

1177-2012 

CODE 

Lot BR7539 


Recalling 

Firm: Sandoz, Inc., Princeton, NJ, by letter on January 5, 2012. 

Manufacturer: Sandoz, Inc., Broomfield, CO. Firm initiated recall is ongoing. 

REASON 

Microbial contamination of non-sterile product (gelatin capsules contamination) 

. 


0.9% Sodium Chloride Injection, 

USP, 500mL, NDC 0409-7983-03. 

. Recall # D-1178-2012 

CODE 

Lot # 06-830-FW 


Recalling 

Firm: Hospira, Inc., Lake Forest, IL, by letter on December 9, 2011. 

Manufacturer: Hospira, Inc., Rocky Mount. NC. Firm initiated recalll is ongoing. 

REASON 

Failed PH 

Specifications: The product is being recalled because of a confirmed out of 

specification result for pH. 


Medroxyprogesterone Acetate Injectable Suspension, USP 150 mg/mL, a) 1mL Vials (NDC 

0703-6801-01); b) box of 25 single dose vials (NDC 0703-6801-04) 

and c) 1mL Prefilled 

Syringes (NDC 0703-6811-21), Rx only, For 

IM Use Only. Recall # D-1180-2012 

CODE 

a) Lot numbers 31310301B, exp 12/2011; 31310788B, exp 1/2012; 31311008B, exp 4/2012; b) 

lot numbers - 31310787B, exp 1/ /2012; 31311357B, exp 4/2012; and 

c) lot numbers 31311217B, 

exp 2/2012; 31311219B, exp 2/2012; 31312156B, exp 4/ /2012; 31312300B, 4/2012. 


21

Recalling 

Firm: Teva 

Pharmaceuticals USA, Inc., Sellersville, PA, by letter on December 1, 

2011. 

Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. Firm initiated recall is 

ongoing. 

REASON 

Presence of Particulate Matter; presence of silicone particles. 

PRODUCT (CLASSS III) 

CHLORHEXIDINE, 

(0.12% CHLORHEXIDINE GLUCONATE), ALCOHOL FREE, ORAL 

RINSE, Mint, Rx Only, Net WT 16 fl. oz. (473 ml), Gelato, Manufactured by: Deepak Products, 

LLC, Miami, FL -- NDC 068400-500-16 ----- ALSO LABELED AS 

CHLORHEXIDINE, 

(0.12% CHLORHEX 

XIDINE GLUCONATE) 

), ALCOHOL FREE, ORAL RINSE, Mint, Rx Only, 

Net WT 16 fl. oz. (473 ml), Gibson Healthcare, Distributed Exclusively by: Benco Dental, 

Pittsburgh, PA --- NDC 066975-500-16, and 

ORA-RINZ, (0.12% CHLORHEXIDINE 

GLUCONATE), ALCOHOL FREE, ORAL RINSE, Mint, Rx Only, , Net WT 16 

fl. oz. (473 ml) 

Manufactured for: Pearson Dental Supply Inc. Sylmar, CA 91342 USA, NDC 068400-155-16. 

Recall # D-1187-2012. 

CODE 

Lot #’s: 110226A, 110420F, 110509, 110721D, 110603D, 110721D, 110901, 111005A, 

110420F, 110314E, 110622B, 110811, 110222A, 110222B, 110223, , 110223A, 110223B, 

110224, 110224A, 110224B, 110225B, 110225C, 110225D, 110225F, 110301B, 110301D, 

110302B, 110302C, 110303A, 110303B, 110413C, 110413D, 110415B, 110414A, 110414B, 

110414C, 110415, 110415A, 110425B,110425c, 110425D, 110426B, 110426C, 110426D, 

110427B, 110427C, 110429C, 110606A, 110607B, 110607C, 110607D, 110622C, 110623, 

110623B, 110623F, 110629B, 110629C, 110629D, 110630A, 110630B, 110630C, 110803A, 

110805, 110805A, 110805B, 110808C, 110818A, 110823A, 1109011 


Deepak Products, Inc., Miami, FL, by letters on December 2, 2011. Firm initiated recall is 

ongoing. 

REASON 

CGMP Deviations. 


Prosed DS Tablets (Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 

mg, 

Benzoic Acid 9.0 mg, and Hyoscyamine Sulfate 0.12 mg), 100 countt bottle, Rx Only, NDC 


CODE 

Lot # 101329 Exp Date 04/12; and Lot # 102285 Exp Date 05/12 


Recalling 

Firm: Ferring Pharmaceuticals Inc., Parsippany, NJ, by letters on September 1, 2011. 

Manufacturer: Contract Pharmacal Corp., Hauppauge, NY. Firm initiated recall is ongoing. 

REASON 

Subpotent (multiple ingredient drug): hyoscyamine sulfate component. 


Xanax, alprazolam tablets, USP, 0.5 mg, 1000 Tablets, Rxx only, NDC 

0009-0055-01. Recall # D- 


CODE 

Lot: C081196 


22

Recalling 

Firm: Pfizer Us Pharmaceutical Group, New York, NY, by 

letters on January 17, 2012. 

Manufacturing Firm 1: Pfizer Pharmaceuticals LLC, Caguas, PR. Firm initiated recall is 

ongoing. 

REASON 

Failed USP Dissolution Test Requirements: Stability testing yielded an out-of-specification 

result for 

assay at the 

36 month stability testing timepoint 


Fluocinonide, Ointment USP, 0.05%, NDC 51672-1264- 

-2. Packaged 

in phenolic 

lacquer 

aluminumm tubes with 

two sizes: 30g UPC: 351672126421; 60g UPC: 351672126438. Recalll # D- 


CODE 

Lot # J9066, 10/12; J9069, 10/12; J9070, 10/ /12; J9071, 10/12; K9001, 11/12; K9002, 11/12; 

K9003, 11/12; K9004, 11/12; K9005, 11/12; K9006, 11/ /12; K9007, 11/12; K9113, 11/12; 

K9114, 11/12; K9115, 11/12; K9116, 11/12; K9117, 11/ /12; K9118, 11/12; K9119, 11/12 


Recalling 

Firm: Taro 

Pharmaceuticals USA, Inc., Hawthorne, NY, by letter on September 28, 

2011. 

Manufacturer: Taro Pharmaceuti 

icals, Inc., Brampton, Canada. Firm initiated recall is ongoing. 

REASON 

Impurities/Degradation Products: Out-of specification result for a known degradant Fluocinolone 

Acetonide. Taro Pharmaceuticals, Inc is recalling specific lots of Fluocinonide Ointment USP, 

0.05% based on an investigation 

regarding out-of-specification (OOS) results for 

a known 

degradant observed in Fluocinonide Ointmen 

USP, 0.05%, long-term 

stability lots # J9066 at 

22-month 

interval, and # K9003 and # K9115 

at 21-month intervals. 

Current Drug Shortages 

Nystatin 

Vaginal Tablets 

November 17, 2011 

Products Affected - Description 

Nystatin Vaginal Tablets, Teva 

100,000 unit tablets, 15 count (NDC 51285-0534-22) 

Reason for the Shortage 

Teva could not provide a reason for the shortage. 

Teva is the sole manufacturer of nystatin vaginal tablets. 

Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=865 

Source: http://www.a 

ashp.org 

Paregoric Liquid 



Paregoric 

liquid, Hi-Tech 

2 mg/5 mL, 480 mL (NDC 50383-0855-16) 


Hi-Tech has temporarily suspended manufacturing paregoric liquid due to manufacturing issues. 

Paregoric 

is also an unapproved drug. 

Actavis discontinued 

d paregoric liquid in January, 2009. 



ashp.org 

23

Liotrix Tablets 



Thyrolar tablets, Forest Laboratories 

12.5/3.1, 100 count (NDC 00456-0040-01) 

25/6.25, 100 count (NDC 00456-0045-01) 

50/12.5, 100 count (NDC 00456-0050-01) 

100/25, 100 count (NDC 00456-0055-01) 

150/37.5, 100 count (NDC 00456-0060-01) 


Thyrolar tablets from 

Forest Laboratories are 

on back order due to manufacturing changes. 

Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=24. 


ashp.org 

Ganciclovir Capsules 



Ganciclovir sodium capsules, Ranbaxy 

250 mg capsules, 180 

count bottles (NDC 63304-0636-28) 

500 mg capsules, 180 

count bottles (NDC 63304-0637-28) 


Ganciclovir capsuless are on back 

order due to 

a raw material shortage.1 There are no other 

supplierss of ganciclovir tablets. 



ashp.org 

Choline Magnesium 

Trisalicylate 




Trisalicylate, Caraco 

500 mg tablets, 100 count (NDC 57664-0219-08) - discontinued 

750 mg tablets, 100 count (NDC 57664-0220-08) - discontinued 

1000 mg tablets, 1000 count (NDC 

57664-0221-08) - discontinued 


Trisalicylate, Marlex 

500 mg tablets, 100 count (NDC 10135-0467-01) 



Caraco has discontinued their product. Product was recently seized by US Marshals due to good 

manufacturing practice violations (see news release for more information). 

Marlex could not provide a reason for their shortage. 



ashp.org 

Metronidazole tablets and capsules 



Metronidazole tablets, Major 

250 mg, 100 count, unit dose (NDC 00904-1453-61) 

Metronidazole tablets, Watson 

24

250 mg, 100 count (NDC 00591-3969-01) - discontinued 

d 


500 mg tablets, 50 count, robot-ready (NDC 00591-3970-50) - discontinued 



Watson states the reason for the shortage is supply constraints. 

Teva discontinued their metronidazole unit dose presentations. 



ashp.org 

Ticlopidine Tablets 



Ticlopidine tablets, Apotex 

250 mg, 30 count (NDC 60505-0027-02) 

250 mg, 60 count (NDC 60505-0027-04) 

250 mg, 500 count (NDC 60505-0027-07) 


Sandoz and Major discontinued their ticlopidine presentations in December, 2009. 

Par discontinued their ticlopidine 

presentations in January, 2009. 

Roche (Genentech) has discontinued Ticlid. 

Apotex has an import ban on their ticlopidine 

presentations. 

Caraco stopped manufacturing all ticlopidine 

presentations in 2009. 



ashp.org 

Prochlorperazine Edisylate Injection 



Prochlorperazine injection 5 mg/ /mL, Bedfordd 

2 mL vial, 10 count (NDC 55390-0077-10) 

10 mL vial (NDC 55390-0077-01) 


Ben Venue voluntarily suspendedd all manufacturing and distribution 

in mid-November, 2011. 

Product will become available in 

stages as production resumes. 

Bedford Laboratories 

has multiple products affected by this suspension of manufacturing. 

Availability of all products, including those not manufactured at Ben 

Venue, is updated as 

information changes on the Bedford Laboratories website. 

Bedford is the sole manufacturer 

r of prochlorperazine injection. 



ashp.org 

Rotigotine Transdermal Systems Patch 



Rotigotine transdermal systems (Neupro), UCB 

2 mg/24 hours, package of 7 (NDC 00091-6486-21) 




25




UCB recalled rotigotine transdermal systemss in March, 2008 due to manufacturing problems 

and 

crystal formation in the patches. In April, 2010, FDA recommended 

reformulation of Neupro 

transdermal systems to prevent crystallization 

n. Remaining supplies of rotigotine have been 

depleted. 



ashp.org 

Octreotide Injectionn 



Octreotide injection, APP 

1000 mcg/mL, 5 mL vial (NDC 63323-0379 

-05) 

Octreotide injection, Bedford 

50 mcg/mL, 1 mL vial (NDC 55390-0160-10) 

100 mcg/ /mL, 1 mL vial (NDC 55390-0161-10) 




-01) 

Octreotide injection, Sandoz 


Octreotide injection, Teva 

50 mcg/mL, 1 mL vial (NDC 00703-3301-04) 





-01) 


APP reports that the shortage is due to increased demandd for the product. 


in mid-November, 2011 on 

a temporary basis for 

maintenance and requalification off equipment. Product will become 

available 

in stages as 

production resumes. 


has temporarily suspended the distribution of Ben Venue Laboratories 

manufactured products. Availability of products is updated on the Bedford Laboratories website. 

Sandoz has octreotide on shortage due to delay of raw materials. 

Teva has 

octreotide on shortage due to manufacturing delays. 

Sandostatin LAR presentations from Novartis are not affected by this shortage. 



ashp.org 

Lansoprazole Orally Disintegrating Tablets 



Lansoprazole orally disintegratin 

ng tablets, Sandoz 

15 mg tablets, 100 count (NDC 00781-5733- 

-13) 


-13) 


Teva discontinued lansoprazole orally disintegrating tablets in February, 2011. 

26

Sandoz states the shortage is due 

to manufacturing issues. 

The shortage is not affecting regular lansoprazole capsules, which are readily available from 

multiple manufacturers. 



ashp.org 

Acyclovir Capsules and Tablets 



Acyclovir capsules and tablets, Apotex 

200 mg capsules, 1000 count (NDC 60505-0042-06) 



60505-5306-08) 



60505-5307-08) 

Acyclovir capsules and tablets, Ranbaxy 




200 mg capsules, 5000 count (NDC 63304-0652-05) - discontinued 

Acyclovir capsules and tablets, Teva 


200 mg capsules, 1000 count, unit 

dose (NDC 

00093-8940-93) 



400 mg tablets, 100 count, unit-dose (NDC 00093-8943- 

-93) 



800 mg tablets, 100 count, unit-dose (NDC 00093-8947- 

-93) 



Apotex has halted manufacturing 

due to an FDA audit. 

Ranbaxy 

has acyclovir capsules and tablets on back order due to a raw materials 

shortage. 

Teva could not provide a reason for the shortage. 



ashp.org 

Cefpodoxime 



Cefpodoxime, Aurobindo 

100 mg tablet, 20 count (NDC 65862-0095-20) 


50 mg/5 mL, 50 mL suspension (NDC 65862-0140-50) 

50 mg/5 mL, 100 mL 

suspensionn (NDC 65862-0140-01) 

) 

100 mg/5 

mL, 50 mL 

(NDC 65862-0141-50) 

100 mg/mL, 100 mL 

suspension (NDC 65862-0141-01) 

Cefpodoxime, Ranbaxy 



27

200 mg tablet, 100 count (NDC 63304-0521- 

-01) 

50 mg/mL, 50 mL suspension (NDC 63304-0965-03) 



100 mg/mL, 100 mL 

suspension (NDC 63304-0966-04) 


Ranbaxy 

has an import ban on all solid medications including cefpodoxime. 

Aurobindo cannot provide a reason for the shortage. 

Pfizer has discontinued Vantin. 

Article Link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=793 


ashp.org 

Diphenhydramine Hydrochlori 

ide for Injection 



Diphenhydramine injection, 50 mg/mL, Hospira 

1 mL Carpuject syringe (NDC 00409-2290-31) 

Diphenhydramine injection, 50 mg/mL, Mylan Institutional 

10 mL vial (NDC 67457-0124-10) 

Diphenhydramine injection, 50 mg/mL, West-Ward (formerly Baxter products) 

1 mL vial (NDC 00641-0376-25) 


West-Ward (formerly 

Baxter products) cannot provide a reason for the shortage. 

APP stated that the shortage was due to increased demand for the product. 

Mylan Institutional has diphenhydramine injection on shortage due to increased demand. The 

company 

is increasing production 

to try to meet this demand. 

Hospira discontinued 

d diphenhydramine iSecure syringes in 2011. 

Pfizer discontinued all Benadryl injection in 2005. 

IMS discontinued diphenhydramine injectionn in April 2008. 



ashp.org 

Fentanyl Injection 



Fentanyl Injection 50 

mcg/mL, Hospira 

10 mL ampules (NDC 



2 mL ampule (NDC 00409-9093-32) 

5 mL ampule (NDC 00409-9093-35) 

20 mL ampule (NDC 

00409-9093-38) 

2 mL vial (NDC 00409-9094-22) 

5 mL vial (NDC 00409-9094-25) 

10 mL vial (NDC 00409-9094-28) 

20 mL vial (NDC 00409-9094-31) 

50 mL vial (NDC 00409-9094-61) 

Fentanyl Injection 50 

mcg/mL, West-Ward (formerly Baxter products) 



30 mL single-dose vial (NDC 10019-0036-82) - discontinued 

2 mL ampule (NDC 10019-0038-67) 

28

5 mL ampule (NDC 10019-0033-72) 


10019-0035-74) 

2 mL vial (NDC 10019-0037-27) 

5 mL vial (NDC 10019-0037-30) 

20 mL vial (NDC 10019-0037-25) 

50 mL vial (NDC 10019-0037-83) 


West-Ward acquired 

Baxter’s fentanyl injection productss in May, 2011. The company cannot 

provide a reason for the shortage. 

Hospira states the shortage is due 

to increased demand and manufacturing delays 

including 

quality improvement 

activities. Hospira is ncreasing production of the ampules 

to help meet the 

demand. 



ashp.org 

Hydromorphone Hydrochloride Low Potency Injection 



Hydromorphone Injection, Hospira 

1 mg/mL, 1 mL Carpuject syringes (NDC 00409-1283-31) 

1 mg/mL, 1 mL ampules (NDC 00409-2552- 

-01) 


2 mg/mL, 1 mL iSecure syringess (NDC 00409-1312-10) 

2 mg/mL, 1 mL ampules (NDC 00409-3356- 

-01) 

2 mg/mL, 1 mL vials 

(NDC 00409-3365-01) 


Hydromorphone Injection, West-Ward 


(NDC 00641-0121-25) 

Dilaudid Injection, Purdue 

2 mg/mL, 1 mL ampules, package of 10 (NDC 59011-0442-10) 

2 mg/mL, 1 mL ampules, package of 25 (NDC 59011-0442-25) 


Hospira has hydromorphone injection on shortage due too manufacturing delays. 

West-Ward could not provide a reason for the shortage. 

Purdue could not provide a reason for the shortage. 

High potency hydromorphone injection (10 mg/mL) is not affected by this shortage. 



ashp.org 

Promethazine Injection 



Promethazine injection, West-Ward 

25 mg/mL 1 mL dosette ampule (NDC 00641-1495-35) 

25 mg/mL 1 mL vial 

(NDC 00641-0928-25) 


(NDC 00641-0929-25) 

50 mg/mL 1 mL Novaplus vial (NDC 00641-0956-25) 

Phenergan injection, West-Ward 

25 mg/mL 1 mL ampule (NDC 60977-0001- 

-01) 


(NDC 00641-6084-25) 

29

50 mg/mL 1 mL dosette vial (NDC 60977-0002-04) 

Promethazine injection, Hospira 

25 mg/mL 1 mL Carpuject syringe (NDC 00409-2312-31) 

25 mg/mL 1 mL iSecure syringe (NDC 00409-2312-02) 

- discontinued 

Promethazine injection, Teva 


(NDC 00703-2191-04) 


(NDC 00703-2201-04) 


Teva and 

West-Ward 

state the shortage is due to manufacturing delays. 

Hospira has promethazine products on back order due to supply interruption. Hospira 

discontinued promethazine 25mg/mL 1 mL iSecure syringe in September 2011. 



ashp.org 

Amiodarone Hydrochloride Injection 



Amiodarone 50 mg/mL injection, APP 

3 mL vials, package of 10 (NDC 63323-0616-03) 

Amiodarone 50 mg/mL injection, Hospira 

3 mL ampules, package of 10 (NDC 00409-4348-35) 

3 mL Novaplus ampules, package of 10 (NDC 00409-4348-49) 

Amiodarone 50 mg/mL injection, Sagent 

3 mL syringes (NDC 

25021-0302-73) 


Amphastar and Baxter have discontinued amiodarone vials. 

Teva discontinued amiodarone injection in 2010. 

Bedford discontinuedd all amiodarone presentations in May, 2011 to concentrate on the 

manufacturing of other products. 

GeneraMedix and Apotex discontinued amiodarone injection some time ago. 

Hospira has amiodarone injectionn on shortage due to manufacturing 

delays. 

APP has amiodarone 

injection on 

shortage due to increased demand. . 

Sagent recalled amiodarone injection in February, 2010 and it is unclear if they will release 

product again. 



ashp.org 

Epinephrine Injection 



Epinephrine injection, 1 mg/mL, American Regent 

1 mL ampule, sulfite-free, package of 25 (NDC 00517-1071-25) 

Adrenalinn injection, 1 mg/mL, JHP 

1 mL vial, preservative-free (contains sulfite), package of 25 (NDC 42023-0122-25) 

Epinephrine injection, 1 mg/mL, Amphastar 

30 mL vial (NDC 00548-9061-00) 


American 

Regent had 

temporarily suspendedd manufacture of most drug products 

in April, 2011. 

American 

Regent resumed manufacturing in Shirley, New 

York in early-May, 2011. 

JHP states the reason 

for the shortage is increased demand. 

30



ashp.org 

Lidocaine Injection 



Lidocaine 0.5% 

Xylocaine 0.5% injection, APP 

5 mg/mL, 50 mL vial (NDC 63323-0484-57) 

Xylocaine 0.5% - MPF injection, APP 


Lidocaine 0.5%, Hospira 

5 mg/mL, 50 mL SD 

Tear Top Vial, preservative-free (NDC 00409-4278-01) 

Lidocaine 1% 

Lidocaine 1% injection, APP 



Xylocaine 1% injection, APP 



Xylocaine 1% - MPF 

injection, APP 


10 mg/mL, 2 mL glass ampule (NDC 63323-0492-80) 

10 mg/mL, 5 mL glass ampule (NDC 63323-0492-89) 



10 mg/mL, 30 mL vial, sterile pack (NDC 63323-0492-31) 

Lidocaine 1% injection, Hospira 

10 mg/mL, 30 mL preservative-free vial (NDC 00409-4279-02) 



10 mg/mL, 2 mL preservative-free glass ampule (NDC 00409-4713-32) 

10 mg/mL, 5 mL preservative-free glass ampule (NDC 00409-4713-02) 

10 mg/mL, 30 mL preservative-free vial, sterile pack (NDC 00409-4270-01) 

Lidocaine 1.5% 

Xylocaine 1.5% - MPF injection, APP 

15 mg/mL, 10 mL ampule (NDC 

63323-0493-97) 


63323-0493-91) 

Lidocaine 2% 

Lidocaine 2% injection, APP 


20 mg/mL, 5 mL SD 

Tear Top vial, preservative-free (NDC 63323-0208-05) 

Xylocaine 2% injection, APP 




20 mg/mL, 10 mL vial (NDC 63323-0486-10) – NDC discontinued 




injection, APP 

31




63323-0496-97) 

Lidocaine 2% injection, Hospira 

20 mg/mL, 2 mL glass ampule, preservative- 

-free (NDC 00409-4282-01) 

20 mg/mL, 5 mL vial, preservative-free (NDC 00409-2066-05) 



20 mg/mL, 10 mL glass ampule, preservative-free (NDC 

00409-4282-02) 


Hospira has lidocaine 

1% and 2% 

presentations on shortage due to manufacturing delays. 

APP has Xylocaine and lidocaine 

presentations on shortage due to increased demand for the 

product. 

Lidocaine emergency 

syringes are not affected by this shortage. 



ashp.org 

Lidocaine with Epinephrine Injection 



Lidocaine 0.5% with 

epinephrinee 

Xylocaine 0.5% (with epinephrine 1:200,0000 injection), APP 


Lidocaine 0.5% (with 

epinephrine 1:200,0000 injection), Hospira 


Lidocaine 1% with epinephrine 

Xylocaine 1% (with epinephrine 1:200,000 injection), APP 





(with epinephrine 1:200,000 injection), APP 




Lidocaine 1% (with epinephrine 

1:100,000) injection, Hospira 


Lidocaine 1.5% with 

epinephrinee 

Xylocaine 1.5% - MPF (with epinephrine 1:200,000 injection), APP 



Lidocaine 1.5% (with 

epinephrine 1:200,0000 injection), Hospira 

15 mg/mL, 5 mL glass ampule, 100 count (NDC 00409-1209-65) 

Lidocaine 2% with epinephrine 

Xylocaine 2% (with epinephrine 1:200,000 injection), APP 




(with epinephrine 1:200,000 injection), APP 




32

Lidocaine 2% (with epinephrine 

1:100,000 injection), Hospira 





Hospira has lidocaine 

with epinephrine presentations on shortage due to manufacturing delays. 

APP has Xylocaine with epinephrine presentations on shortage due to increased demand for the 

product. 



ashp.org 

Atropine 

Sulfate Injection 



Atropine injection, Hospira 

0.05 mg/ /mL, 5 mL Ansyr syringe, package of 10 (NDC 00409-9630-05) 

Atropine injection, American Regent 

0.4 mg/mL, 0.5 mL ampule, package of 25 (NDC 00517-0805-25) 

0.4 mg/mL, 1 mL single-dose vial, package of 25 (NDC 00517-0401-25) 

1 mg/mL, 1 mL single-dose vial, 

package of 

25 (NDC 00517-1010-25) 

1 mg/mL, 1 mL ampule, package 

of 25 (NDC 

00517-0101-25) 

Atropine injection, West-Ward (formerly Baxter) 

0.4 mg/mL, 1 mL single-dose vial, package of 25 (NDC 10019-0250-12) 

0.4 mg/mL, 20 mL multi-dose vial, package of 10 (NDC 

10019-0250-20) 

1 mg/mL, 1 mL single-dose vial, 

package of 

25 (NDC 10019-0251-12) 


American 

Regent had 



American 




to manufacturing delays. 

West-Ward could not provide a reason for the shortage. 



ashp.org 

Calcium 

Chloride Injection 



Calcium Chloride 100 mg/mL Injection, Hospira 

100 mg/mL, 10 mL Ansyr syringe (NDC 00409-1631-10) 

100 mg/mL, 10 mL LifeShield syringe (NDC 

00409-4928-34) 


American 

Regent had 

temporarily suspendedd distributionn of most drug products including 

calcium chloride in April, 2011. 

American 



Hospira has calcium chloride on shortage due to manufacturing delays. 



ashp.org 

Cilostazol Tablets 



33

Cilostazol tablets, Apotex 

50 mg, 60 count (NDC 60505-2521-01) 

100 mg, 60 count (NDC 60505-2522-01) 

Cilostazol tablets, Teva 



Sandoz had cilostazol in short supply due to a shortage of raw materials. 

Apotex and Teva cannot provide 

a reason for 

the shortage. 

Mylan discontinued cilostazol tablets in August, 2011. 



ashp.org 

Clarithromycin Immediate-Release Tablets 



Clarithromycin immediate-release tablets, Apotex 

250 mg, 60 count (NDC 60505-2616-06) 

500 mg, 60 count (NDC 60505-2615-06) 

Clarithromycin immediate-release tablets, Mylan 

250 mg, 60 count (NDC 00378-8250-91) 

500 mg, 60 count 9NDC 00378-8500-91) 

Clarithromycin immediate-release tablets, Ranbaxy 

250 mg, 60 count (NDC 63304-0725-60) 

250 mg, 100 count (NDC 63304-0725-01) 

500 mg, 60 count (NDC 63304-0726-60) 

500 mg, 100 count (NDC 63304-0726-01) 

Clarithromycin immediate-release tablets, Sandoz 

250 mg, 60 count (NDC 00781-1961-60) 

500 mg, 60 count (NDC 00781-1962-60) 

Biaxin immediate-release tablets, Abbott 

250 mg, 100 count unit dose (NDC 00074-3368-11) - discontinued 

250 mg, 60 count (NDC 00074-3368-60) 



Ranbaxy 

has an import ban on their products. 

Apotex import ban has been lifted, but the company has not resumed 

production 

of 

clarithromycin immediate-releasee tablets. 

Abbott, Mylan, and Sandoz and cannot provide a reason for the shortage. 



ashp.org 

Echothiophate Powder for Ophthalmic Solution 



Phospholine Iodide 0.125%, Pfizer 

5 mL bottle (NDC 00046-1065-05) 


Pfizer (formerly Wyeth) states Phospholine Iodide is in short supply due to a raw 

material 

shortage. 


34


ashp.org 

Haloperidol Decanoate Injection 



Haloperidol decanoate injection, Bedford 

50 mg/mL, 1 mL vials (NDC 55390-0412-01) - discontinued 

50 mg/mL, 5 mL vials (NDC 55390-0412-05) - discontinued 

100 mg/mL, 1 mL vial (NDC 55390-0413-01) - discontinued 


Haloperidol decanoate injection, Teva 





Haloperidol decanoate injection, Apotex 



50 mg/mL, 5 mL Novaplus vial (NDC 60505-6020-02) - discontinued 


100 mg/mL, 5 mL Novaplus vial 

(NDC 60505-6021-02) 


Haldol decanoate injection, Ortho-McNeil 

50 mg/mL, 1 mL ampule, 10 count (NDC 00045-0253-01) - discontinued 

50 mg/mL, 1 mL ampule (NDC 00045-0253 

-03) – NDC number discontinued 

100 mg/mL 1 mL ampule (NDC 00045-0254-14) – NDC 

number discontinued 


Teva products are on 

shortage due to manufacturing delays. 

Bedford discontinuedd haloperidol decanoate in May, 2011 to concentrate on the manufacturing 

of other products. 

Apotex has discontinued all haloperidol decanoate presentations. 

Ortho-McNeil discontinued the 50 mg/mL 1 mL ampule 10 count presentations 

in late-June, 

2010. 



ashp.org 

Haloperidol Lactate 

Injection 



Haloperidol lactate 5 mg/mL injection, Bedford 

1 mL vial (NDC 55390-0147-10) 

10 mL vial (NDC 55390-0147-01) 

Novaplus 

1 mL vial (NDC 55390-0447-10) 


Haloperidol lactate 5 mg/mL injection, Pfizer 

1 mL vial (NDC 00069-0113-02) 

Haloperidol lactate 5 mg/mL injection, Teva 

1 mL vial (NDC 00703-7041-03) 

10 mL vial (NDC 00703-7045-01) 

Haloperidol lactate 5 mg/mL injection, Ortho-McNeil 


00045-0255-01) - NDC 

number discontinued 


APP and Pfizer have haloperidoll lactate on shortage due to increased 

demand. 

35





available 

in stages as 





Teva has 

haloperidoll lactate on shortage due to manufacturing delays. 



ashp.org 

Heparin 

Sodium Injection 



Heparin Sodium for Injection 

Heparin sodium injection, APP 

10,000 unit/mL, 0.5 mL single-dose vial (NDC 63323-0543-02) 

Heparin sodium injection, Hospira 

10,000 unit/mL, 0.5 mL Carpuject Luer Lock 

Slim-Pak, package of 10 (NDC 00409-1316-66) 

Heparin Sodium Flush Solution 

Heparin sodium flush 

for injection, APP 

10 units/mL, 10 mL multiple-dos 

se vial (NDC 

63323-0544-11) 


solution for injection, Hospira 

10 unit/mL, 10 mL multiple-dose 

e vial (NDC 00409-1151-70) 

10 unit/ mL, 2 mL, Luer lock syringe (NDC 00409-1280-32) 

10 unit/mL, 3 mL Luer lock syringe (NDC 00409-1280-33) 

100 unit/ /mL, 4 mL multiple-dose 

e vial (NDC 00409-1152-70) 

100 unit/ /mL, 2 mL multiple-dose 

e vial (NDC 00409-1152-78) 


solution for injection, Covidien 

10 unit/mL, 3 mL prefilled syringe (NDC 17474-0123-03) 

100 unit/ /mL, 3 mL prefilled syringe (NDC 17474-0125-03) 

100 unit/ /mL, 10 mL prefilled syringe (NDC 17474-0125-01) 

Heparin sodium large 

volume infusion solutions 

Heparin sodium large 

volume infusion solutions, Hospiraa 

12,500 unit/250 mL in 0.45% Sodium Chloride injectionn (NDC 00409-7651-62) 

12,500 unit/250 mL in Dextrose 5% injectionn (NDC 00409-7794-62) 

) 

20,000 unit/250 mL in Dextrose 5% injectionn (NDC 00409-7760-03) 

) 



25,000 unit/ 250 mL in Dextrosee 5% injection (NDC 00409-7793-62) 

25,000 unit/ 500 mL in Dextrosee 5% injection (NDC 00409-7761-03) 


Baxter has recalled all single-dose and multiple-dose vials of heparin 

sodium 1,000 unit/mL, 

5,000 unit/mL and 10,000 unit/mL concentrations, as well as all heparin lock flush products (i.e., 

10 unit/mL and 100 unit/mL). In early 2008, Baxter recalled nine lots of the 1,000 unit/mL 

concentration and temporarily stopped manufacturing alll multiple-dose vials of its 1,000 

unit/mL, 5,000 unit/mL, and 10,000 unit/mL heparin sodium injection, due to recent reports of 

severe allergic reactions in patients receiving 

bolus dosess of these products. However, the 

warning was broadened to include all heparin 

vial products in all concentrations, 

as these are 

obtained from the same source manufacturer 

r. Baxter has stopped manufacturing 

and shipping 

these products in order to investigate the cause of these adverse events. In late November, 2009 

Baxter announced that all large volume heparin sodium in Dextrose 5% premix solutions will 

36

ecome unavailable for an extended time period. The company is working to implement new 

manufacturing procedures associated with the new USP reference standard for heparin products. 

Large volume heparin sodium in 0.9% sodium 

chloride is available. 

West-Ward obtained 

five presentations of the 

heparin sodium injection from Baxter in 

September, 2011. Baxter only retained two large volumee heparin presentations. All other Baxter 

presentations have been discontinued. 

APP was 

allocating supplies of its heparin sodium in response to the 

Baxter action. APP reports 

that heparin-lock products are on 

back order due to increased demand for the product. 

Hospira states the shortage of heparin vials is 

due to supply and demand issues. In January, 2010 

Hospira announced that all large volume heparin sodium 

in Dextrosee 5% premix 

solutions and 

one presentation of heparin sodium in 0.45% 

sodium chloride (NDC 

00409-7650-62) will be 

unavailable through the end of March, 2010. The company is working to implement new 

manufacturing procedures associated with the new USP reference standard for heparin products. 

The company states the large volume solutions formulated in either Dextrose 5% 

or 0.45% 

Sodium Chloride are specifically 

affected because of thee impact pH differences have on the new 

testing. 

B. Braun 

recalled 23 lots of their 

heparin sodium large volume infusion solutions as a 

precautionary measure after their 

supplier found a heparin-like contaminant in one lot of raw 

material. Product subject to the recall was distributed in both the US and Canada, including: 

Heparin sodium 1,000 unit/500 mL in 0.9% Sodium Chloride injection (NDC 00264-9872-10): 

Lot numbers J7C477, J7C557, J7C611, J7C705, J7D485, J7E415, J7E416, J7E589, J7N519, 

and 

J7N676. 

Heparin sodium 20,000 unit/500 mL in Dextrose 5% injection (no NDC number, not distributed 

in US): Lot number J7D580 

Heparin sodium 25,000 unit/250 mL in Dextrose 5% injection (NDC 

00264-9587-20): Lot 

numbers J7C470, J7D490, J7E420 (not distributed in US), J7E494, J7N556, and 

J7P476. 

Heparin sodium 25,000 unit/500 mL in Dextrose 5% injection (NDC 

00264-9577-10): Lot 

numbers J7C684, J7D496, J7E500, J7E577 (not distributed in US), J7N604, and 

J7P404. 

Covidien 

recalled 32 lots of prefilled heparin 

lock syringes after their supplier found a heparin- 

like contaminant in two lots of raw material. The affectedd lots include: 

Heparin sodium 10 unit/mL, 2.5 mL lock flush syringe, NDC 17474-0123-02 (Lot 7051444) 

Heparin sodium 10 unit/mL, 3 mL lock flush 

syringe, NDC 17474-0123-03 (Lots 7051524, 

7113214) 



7082274, 7113164, 7113174) 


syringe with Bluntip cannula, NDC 

08881-1571-25 

(Lot 7082274) 

Heparin sodium 10 unit/mL, 10 mL lock flush syringe, NDC 17474-0123-01 (Lot 7082274, 

7113214) 

Heparin sodium 100 unit/mL 3 mL lock flush 


7072154, 7113034, 8010194) 



7041204, 7051534, 7051544, 7051554, 7071924, 7072034, 7072044, 7072054, 7072064, 

7072154, 7082284, 7102804, 7113034, 7113044, 7113054, 7113104, 7113114, 7113154, 

8010064, 8010114, 8010134, 8010174) 


syringe with Bluntip cannula, NDC 

08881-5911- 

25 (Lot 7082284) 

Heparin sodium 100 unit/mL 10 mL lock flush syringe, NDC 17474-0125-01 (Lot 7113064) 



ashp.org 

37

Labetalol Injection 



Labetalol injection 5 mg/mL, Akorn 

40 mL vials (NDC 17478-0420-40) 

Labetalol injection 5 mg/mL, Bedford 

20 mL vials (NDC 55390-0130-20) 

40 mL vials (NDC 55390-0130-40) 

Labetalol injection 5 mg/mL, Hospira 


Labetalol injection 5 mg/mL, Sagent 

20 mL vials (NDC 25021-0300-20) 

40 mL vials (NDC 25021-0300-40) 






available 

in stages as 



has multiple products affected by this temporary suspension of 

manufacturing. Bedford will have the affected, as well ass the available products, 

listed on their 

website and are updating this information as it changes. 

Hospira has labetaloll on shortage 

due to manufacturing delays. 

Sagent could not provide a reason for the shortage. 

Akorn states the reason for the shortage is demand exceeding supply. 

Apotex discontinued 

d their 4 mL vials (NDC 60505-0717-00) in February, 2010. The company 

could not 

provide a reason for the discontinuation. 



ashp.org 

Sodium Bicarbonate Injection 



Sodium Bicarbonate 

Injection 8.4%, Amphastar (IMS) 

50 mL Min-I-Jet (NDC 00548-1052-00) - discontinued 

50 mL Stick-Gard (NDC 00548-2052-00) - discontinued 

d 


Injection 8.4%, American Regent 

50 mL vial (NDC 00517-1550-25) - discontinued 


Injection 7.5%, American Regent 

50 mL vial (NDC 00517-0639-25) 


Injection 4.2%, APP 

5 mL vial (NDC 63323-0026-05) 


Injection 4.2%, Hospira 

10 mL syringe, 10 count (NDC 00409-5534- 

-34) 

Neut 4% sodium bicarbonate additive solution, Hospira 

5 mL vial (NDC 00409-6609-02) 


American 

Regent discontinued their sodium bicarbonate 8.4% 50 mL 

vials in 1st quarter, 2011. 

American 

Regent had 


sodium bicarbonate. 

38

American 



Hospira had sodium bicarbonate on back order due to manufacturing 

delays. 


d their sodium 

bicarbonate 8.4% 50 mL Ansyr syringes in August, 2009. 

APP has sodium bicarbonate on back order due to increased demand. 



ashp.org 

Metoprolol Injection 



Metoprolol 1 mg/mL 

Injection, American Regent 



Injection, APP 



Injection, Bedford 


5 mL Novaplus vial, 10 count (NDC 55390-0348-10) 


Injection, Hospira 

5 mL ampule, 12 count (NDC 00409-2285-05) 

5 mL vial (NDC 00409-1778-05) 

Lopressor 1 mg/mL Injection, Novartis 

5 mL ampule, 10 count (NDC 00078-0400-01) 


Injection, Sandoz 



American 

Regent had 


including 

metoprolol in April, 2011. 

American 



APP and Hospira state the shortage is due to increased demand for the product. 





available 

in stages as 







ashp.org 

Methylphenidate Hydrochloride 



Extended-Release Presentations 

Methylin 

ER, Mallinckrodt 


-01) 


-01) 

Metadatee ER, UCB 


-07) 

Immediate Release Presentations 

s 

Methylin, Mallinckrodt 


5 mg tablets, 1000 count (DC 00406-1121-10) 

39


-01) 



-01) 


Ritalin, Novartis 


Methylphenidate, Sandoz 



-01) 


-01) 

Methylphenidate, Watson 



-01) 


-01) 

Methylphenidate, UCB 



-07) 


-07) 


Novartis and UCB cannot provide a reason for the shortage. 

Mallinckrodt states the shortage is due to delay in the release of theirr DEA quota. 

Sandoz states that the 

shortage is 

due to delay in obtaining raw materials. 

JOM could not provide a reason for the shortage. 

Watson states the shortage is due 

to increased 

demand for their products. 



ashp.org 

Labetalol Tablets 



Labetalol tablets, Major 

200 mg, 100 count (NDC 00904-5929-61) 

Labetalol tablets, Sandoz 

100 mg, 100 count (NDC 00185-0010-01) 

100 mg, 500 count (NDC 00185-0010-05) 

200 mg, 100 count (NDC 00185-0117-01) 

200 mg, 500 count (NDC 00185-0117-05) 

300 mg, 100 count (NDC 00185-0118-01) 

300 mg, 500 count (NDC 00185-0118-05) 

Labetalol tablets, Teva 


100 mg, 500 count (NDC 00172-4364-70) 


Labetalol tablets, UDL 


Labetalol tablets, Watson 

100 mg, 100 count (NDC 00591-0605-01) 

200 mg, 100 count (NDC 00591-0606-01) 

200 mg, 500 count (NDC 00591-0606-05) 

300 mg, 100 count (NDC 00591-0607-01) 

40

Trandate tablets, Prometheus 

100 mg, 100 count (NDC 65483-0391-10) 

200 mg, 100 count (NDC 65483-0392-10) 

300 mg, 100 count (NDC 65483-0393-10) 


Major, Sandoz, Teva, Prometheus cannot provide a reason for the shortage. 

Watson has labetaloll tablets on back order due to increased demand. 



ashp.org 

Vancomycin Hydrochloride Injection 



Vancomycin hydrochloride injection, Mylan Institutional 

1 gram vial (NDC 10139-0501-12) - NDC discontinued 

Vancomycin hydrochloride injection, Akorn 

500 mg vial (NDC 23360-0151-40) - discontinued 

1 gram vial (NDC 23360-0152-50) - discontinued 

5 gram vial (NDC 23360-0153-65) - discontinued 

Vancomycin hydrochloride injection, Hospira 

750 mg vial (NDC 00409-6531-02) 

1 gram Add-Vantage 

vials (NDC 

00409-6535-01) 

5 gram vial (NDC 00409-6509-01) 

10 gram vial (NDC 00409-6510- 

-01) 

10 gram Novaplus vials (NDC 00409-6510-49) 


Hospira has vancomycin on shortage due to manufacturin 

ng delays. 

Akorn has sold their vancomycinn products to 

Pfizer and stopped distributing on April, 29, 2011. 

Mylan Institutional ( formerly Bioniche) has acquired multiple products from Generamedix, 

including 

vancomycin hydrochloride. 

Pfizer acquired multiple products 

from Akorn, includingg vancomycinn hydrochloride in early- 

May, 2011. 



ashp.org 

Sucralfate Oral Presentations 



Sucralfate tablets, Teva 

1 gram, 500 count (NDC 00093-2210-05) 

1 gram, 100 count (NDC 00093-2210-01) 

Sucralfate tablets, UDL 

1 gram, 25 count unit-dose, robot-ready (NDC 51079-0871-19) 

1 gram, 100 count unit-dose (NDC 51079-0871-20) 


Teva, Watson and Axcan could not provide a reason for the shortage. 

UDL temporaroli discontinued their sucralfate products due to a raw 

materials shortage. 



ashp.org 

41

Ranitidine Injectionn 



Ranitidine 25 mg/mL 

injection, Bedford 

2 mL vial (NDC 55390-0616-10) 

6 mL vial (NDC 55390-0616-01) 

40 mL vial (NDC 55390-0618-01) 

Zantac 25 mg/mL injection, GlaxoSmithKline 

2 mL vial (NDC 00173-0362-38) 


6 mL vial (NDC 00173-0363-01) 








available 

in stages as 





GlaxoSmithKline sold Zantac injection to Covis Pharma a in late-December, 2012. 

Oral ranitidine products are not affected by this shortage. 



ashp.org 

Oxymorphone Hydrochloride 



Extended-Release Presentations 

Opana ER, Endo 



-70) 


-70) 


-70) 


-70) 

Immediate-Release Presentations 

s 

Opana, Endo 



-70) 

Oxymorphone, Endo 



-70) 

Oxymorphone, Roxane 



-25) 


Novartis voluntarily suspended all manufacturing and distribution from its Lincoln, Nebraska 

facility in 

early-January 2012 due to a potential for mixing of different products within a single 

bottle. Novartis plans 

to gradually resume manufacturingg at this facility after manufacturing 

improvements are implemented. 

Several Endo products that are manufactured 

at the Lincoln, Nebraska plant, are affected by this 

manufacturing suspension, including oxymorphone, Opana, and Opana ER. 

Roxane could not provide a reason for this shortage. 

42



ashp.org 

Nitazoxanide Tablets 



Alinia, Romark Laboratories 

500 mg tablets, 30 count bottles (NDC 67546-0111-12) 

500 mg tablets, 60 count bottles (NDC 67546-0111-11) 

100 mg/5 

mL powder for suspension, 60 mL 

bottle (NDC 

67546-0212-21) 


Romark states the reason for the shortage is manufacturin 

ng delay. 



ashp.org 

Metoclopramide Injection 



Metoclopramide injection, Hospira 


(NDC 00409-341401) 


Baxter had metoclopramide injection on back 

order due to regulatory 

issues. Baxter sold some 

generic injectable products to West-Ward. West-Ward then discontinued the metoclopramide 

injection in January, 2012. 

Teva discontinued metocloprami 

ide injectionn in February, 2011. 


d metoclopramide ampules in February, 2010, and Carpuject 

syringes in 

May, 2009. Hospira is the only manufacturer 

r of metoclopramide injection. 



ashp.org 

Glycopyrrolate Injection 



Glycopyrrolate 0.2 mg/mL injection, West-Ward 

1 mL vial (NDC 10019-0016-81) 

2 mL vial (NDC 10019-0016-17) 

5 mL vial (NDC 10019-0016-54) 

20 mL vial (NDC 10019-0016-02) 

Robinul 0.2 mg/mL injection, West-Ward 

1 mL vial (NDC 60977-0155-01) 

2 mL vial (NDC 60977-0155-02) 

5 mL vial (NDC 60977-0155-03) 

20 mL vial (NDC 60977-0155-06) 


West-Ward has acquired all Baxter Robinul and generic glycopyrrolate injectionn products. West- 

Ward cannot provide 

a reason for the shortage. 

American 

Regent had 



American 





ashp.org 

43

Cyanocobalamin Injection 



Cyanocobalamin injection, American Regent 


American 

Regent had 


including 

cyanocobalamin injection in April, 2011. 

American 



APP had cyanocobalamin injection on shortage due to increased demand for the product, but 

has 

product readily available at this time. 



ashp.org 

Calcium 

Acetate Capsules 



Calcium acetate capsules, Roxane 


PhosLo capsules, Fresenius 



Roxane and Fresenius cannot provide a reason for the shortage. 



ashp.org 

Butorphanol Injection 



Butorphanol injection, Bedford 

1 mg/mL 

1 mL vial (NDC 55390-0183-01) 

1 mg/mL 

1 mL Novaplus vial (NDC 55390-0341-10) 

2 mg/mL 

1 mL vial (NDC 55390-0184-01) 

2 mg/mL 

2 mL vial (NDC 55390-0184-02) 

2 mg/mL 


2 mg/mL 

10 mL vial 

(NDC 55390-0185-10) 

Butorphanol injection, Hospira 

1 mg/mL 

1 mL vial (NDC 00409-1623-01) 

2 mg/mL 

1 mL vial (NDC 00409-1626-01) 

2 mg/mL 

2 mL vial (NDC 00409-1626-02) 

Butorphanol injection, West-Ward 

1 mg/mL 


2 mg/mL 



Apotex discontinued 

d butorphanol injection in 

2008. 





available 

in stages as 


44


has multiple products affected by this temporary suspension of 

manufacturing. Bedford will have the affected, as well ass the available products, 

listed on their 

website and are updating this information as it changes. 


to increased demand. 

West-Ward has discontinued butorphanol injection. 

Sandoz discontinued 

d Stadol injection in 2010. 



ashp.org 

Aprepitant Capsules 



Emend 40 mg capsules, Merck 


Merck is the sole supplier of Emend (aprepitant) capsules. 

Merck could not provide a reason 

for this shortage. 

The shortage is not affecting Emend 80 mg or 125 mg capsules, which are labeled for preventing 

chemotherapy induced nausea and vomiting (CINV). Emend 40 mg capsules are 

labeled to 

prevent postoperative 

e nausea and 

vomiting (PONV). 



ashp.org 

Tetracycline Capsules 

February 



Tetracycline capsules, Teva 

250 mg, 100 count (NDC 00172-2416-60) 

250 mg, 100 count unit dose (NDC 00172-2416-10) 

250 mg, 1000 count (NDC 00172-2416-80) 

500 mg, 100 count (NDC 00172-2407-60) 

500 mg, 100 count unit dose (00172-2407-10) 

500 mg, 1000 count (NDC 00172-2407-80) 

Tetracycline capsules, Watson 

250 mg, 100 count (NDC 00591-2234-01) 

250 mg, 1000 count (NDC 00591-2234-10) 

500 mg, 100 count (NDC 00591-2235-01) 

500 mg, 1000 count (NDC 00591-2235-10) 


Teva states tetracycline capsules are unavailable due to a raw material shortage. 

Watson could not provide a reason for the shortage. 



ashp.org 

Leflunomide Tablets 




Leflunomide tablets, Sandoz 

10 mg, 30 count (NDC 00781-5056-31) 

20 mg, 30 count (NDC 00781-5057-31) 

Leflunomide tablets, Teva 

45

20 mg, 30 count (NDC 00093-0174-56) 


Apotex relaunched leflunomide tablets in August 2011. 

Teva had 

leflunomide tablets on shortage due 

to unavailability of raw 

material. 

Sandoz had leflunomide tablets on shortage due to increased demandd and delay of raw material. 



ashp.org 

Furosemide Injection 




Furosemide Injection, 10 mg/mL, Hospira 

4 mL vial (NDC 00409-6102-04) 

2 mL Carpuject syringe (NDC 00409-1275-32) - discontinued 

Furosemide Injection, 10 mg/mL, American Regent 

4 mL vial (NDC 00517-5704-25) 

10 mL vial (NDC 00517-5710-25) 

Furosemide Injection, 10 mg/mL, APP1 

4 mL vial (NDC 63323-0280-04) 


APP has furosemide injection on 

shortage due to increased demand for the product. 

American 

Regent had 


including 

furosemide in April, 2011. 

American 



Hospira has furosemide on shortage due to manufacturin 

ng delays. 

Wockhardt has discontinued all furosemide injection presentations. 



ashp.org 

Diclofenac 1% Gel 




Voltaren gel, Endo 

100 gram, 3 count (NDC 63481-0684-03) 

100 gram, 5 count (NDC 63481-0684-05) 


Endo is the sole supplier of Voltaren gel. 

Endo could not provide a reason for the shortage. 

This shortage is not affecting Pennsaid 1.5% solution, another topical diclofenacc preparation 

for 

treating osteoarthritis 

s symptoms. 



ashp.org 

Thiothixene Capsules 




Thiothixene capsules, Sandoz 



10 mg capsules, 100 count (NDC 


46

Thiothixene capsules, Mylan 


00378-2002-10) 


00378-3005-10) 


Navane capsules, Pfizer 









to a delay in 

acquiring raw materials. 

Sandoz has temporarily discontinued the 2 mg, 5 mg, andd 10 mg presentations. 

Pfizer discontinued Navane (thiothixene) 2 mg, 10 mg, and 20 mg presentations 

in the fall of 

2011. The Navane 5 mg presentation was discontinued previously. 

Mylan could not provide a reason 

for the shortage. 

Mylan discontinued thiothixene 

10 mg 1000 count capsules in the first half of 2011. 



ashp.org 

Amphetamine Mixed Salts, Immediate-Release Tablets 




Amphetamine mixed 

salts immediate-releasee tablets, Teva 


7.5 mg tablets, 100 count (NDC 00555-0775-02) 


-02) 

12.5 mg tablets, 100 count (NDC 

00555-0776-02) 


-02) 


-02) 


-02) 

Adderall, Teva 


7.5 mg tablets, 100 count (NDC 00555-0763-02) 


-02) 

12.5 mg tablets, 100 count (NDC 

00555-0765-02) 


-02) 


-02) 


-02) 


salts immediate-releasee tablets, Sandoz 



-01) 


-01) 


-01) 


salts immediate-releasee tablets, CorePharma 



-10) 


-10) 


-10) 


Teva states the shortage is due to 

DEA quota 

restrictions. 

47

CorePharma cannot provide a reason for the shortage. 


to increased 

demand. 



ashp.org 

Valsartan Tablets 




Diovan tablets, Novartis 

40 mg, 100 count, unit-dose (NDC 00078-0423-06) 

160 mg, 90 count (NDC 00078-0359-34) 

160 mg, 7000 count (NDC 00078-0359-17) 

160 mg, 100 count, unit-dose (NDC 00078-0359-06) 

320 mg, 90 count (NDC 00078-0360-34) 


Novartis is the sole supplier of valsartan tablets. 

Novartis could not provide a reason for the shortage. 



ashp.org 

Ondansetron Injection 2 mg/mL 




Ondansetron 2 mg/mL vials 

Ondansetron injection, 2 mg/mL, APP 


Ondansetron injection, 2 mg/mL, Apotex 

2 mL vials, package of 5 (NDC 60505-0744- 

-01) - discontinued 

20 mL multiple dose vial (NDC 60505-0744 

-06) - discontinued 

Ondansetron injection, 2 mg/mL, Baxter 

1 mL vials (NDC 10019-0905-17) - discontinued 

Ondansetron injection, 2 mg/mL, Bedford 

20 mL vial (NDC 55390-0121-01) 

2 mL vials, packages 

of 10 (NDC 


2 mL Novaplus vials, packages of 10 (NDC 55390-0307-10) - discontinued 

20 mL Novaplus vials, packages of 1 (NDC 55390-0307-01) - discontinued 

Ondansetron injection, 2 mg/mL, Caraco 




Ondansetron injection, 2 mg/mL, Cura 


of 5 (NDC 46860-0087-06) - discontinued 

Ondansetron injection, 2 mg/mL, Hospira 

2 mL iSecure syringe 

(NDC 00409-1120-62) 

- NDC discontinued 

2 mL iSecure syringe 

(NDC 00406-1120-12) 


of 25 (NDC 

00409-4755-03) 

20 mL vials (NDC 00409-4795-01) 

Ondansetron injection, 2 mg/mL, Pfizer 


20 mL vials (NDC 00069-1340-02) 

Ondansetron injection, 2 mg/mL, West-Ward 

(formerly Baxter products) 

48



of 25 (NDC 

00641-6078-25) 

2 mL Novaplus vials, packages of 25 (NDC 00641-6080 

0-25) 

20 mL vials (NDC 10019-0906-03) 

Ondansetron injection, 2 mg/mL, West-Ward 


of 5 (NDC 00143-9891-05) 


of 25 (NDC 

00143-9891-25) 

20 mL vials (NDC 00143-9890-01) 

Ondansetron injection, 2 mg/mL, Teva 




of 25 (NDC 

00703-7221-04) 

20 mL vials (NDC 00703-7226-01) 

20 mL vials, packages of 10 (NDC 00703-7226-03) 

Ondansetron injection, 2 mg\mL, Wockhardt 


of 5 (NDC 64679-0726-01) 

20 mL vials (NDC 64679-0727-01) 

Zofran injection, 2 mg/mL, GlaxoSmithKline 



Ondansetron 32 mg/50 mL premixed bags 

Ondansetron injection, premixed 

bags, Claris 

32 mg/50 

mL (NDC 36000-0014-06) 


bags, Pfizer 

32 mg/50 

mL (NDC 00069-0700-12) - discontinued 


bags, Sagent 

32 mg/50 



bags, Teva 

32 mg/50 

mL (NDC 00703-7239-39) 


bags, Hospira 

32 mg/50 

mL (NDC 00409-4760-24) 


bags, West-Ward 

32 mg/50 



Ondansetron 2 mg/mL vials 

Apotex, Sagent and Cura have discontinued their ondansetron injection. 

APP has ondansetronn on shortage 

due to increased demand for the product. 

Teva discontinued ondansetron 2 mL vials in 

5 count packages. 

Caraco temporarily discontinued 

d ondansetronn injection. 

Baxter has discontinued their ondansetron injection 1 mL 

vial. Baxter states the shortage of their 

2 mL and 

20 mL vials was due to 

increased demand for the product. 


Baxter’s ondansetron vials for injection. West-Ward discontinued the 

ondansetron 20 mL vials in October, 2011. 

Bedford discontinuedd ondansetron 2 mg/mL 2 mL vials in May, 2011 to concentrate on the 

manufacturing of other products. 










GlaxoSmithKline have discontinued Zofran 2 mL vials. 

Hospira has ondansetron on shortage due to quality improvement issues. 

49

Ondansetron 32 mg/50 mL premixed bags 

Hospira has ondansetron premixed bags on shortage due to changes in the manufacturing 

process. 

Claris recalled all lots of their ondansetron premixed bags in mid-2010. 

Pfizer discontinued their ondansetron premixed bags in January, 2012. 

Sagent has discontinued their ondansetron premixed bags. 

Teva has 

ondansetronn premixed bags on shortage due to manufacturing delays. 

West-Ward has discontinued their ondansetron premixedd bags. 



ashp.org 

Metformin Oral Tablets 




Metformin tablets, Amneal 

500 mg extended release, 90 count (NDC 53746-0178-90) - discontinued 

Metformin tablets, Apotex 

500 mg, 100 count (NDC 60505-0190-00) 

500 mg, 500 count (NDC 60505-0190-01) 

500 mg, 1000 count (NDC 60505-0190-08) 

500 mg, 4500 count (NDC 60505-0190-04) 

850 mg, 100 count (NDC 60505-0191-00) 

850 mg, 500 count (NDC 60505-0191-01) 

850 mg, 1000 count (NDC 60505-0191-08) 

850 mg, 2500 count (NDC 60505-0191-04) 

1000 mg, 100 count (NDC 60505-0192-00) 

1000 mg, 500 count (NDC 60505-0192-01) 

1000 mg, 1000 count 

(NDC 60505-0192-08) 

1000 mg, 2000 count 

(NDC 60505-0192-04) 

500 mg extended release, 100 count (NDC 60505-0260-01) 



Metformin tablets, Glenmark 

1000 mg, 1000 count 

(NDC 68462-0161-10) 

Metformin tablets, Mutual Pharmaceuticals 


d 


d 



d 


d 




1000 mg, 1000 count 

(NDC 53489-0469-10) 


Metformin tablets, Mylan 

500 mg, 100 count (NDC 00378-0234-01) 

850 mg, 100 count (NDC 00378-0240-01) 



d 


50


Metformin tablets, Ranbaxy 


d 


d 


d 

Metformin tablets, Sandoz 

500 mg, 12 x 60 package (NDC 00781-5050 

-61) 

850 mg, 12 x 60 package (NDC 00781-5051 

-61) 

1000 mg, 12 x 60 package (NDC 

00781-5052-61) 

Metformin tablets, Teva 

500 mg, 100 count, unit dose (NDC 00093-1048-93) - discontinued 

850 mg, 100 count, unit dose (NDC 00093-1049-93) - discontinued 

1000 mg, 100 count, unit dose (NDC 00093-7214-93) - discontinuedd 

Metformin tablets, UDL 

850 mg, 100 count, unit-dose (NDC 51079-0973-20) - discontinued 




Metformin tablets, Watson 


1000 mg, 1000 count 

(NDC 62037-0676-10) 



Mylan, UDL, and Teva could not provide a reason for the shortage. 

Apotex has metformin products unavailable due to an FDA import ban. 

Sandoz has metformin products on shortage due to manufacturing delays. 

Ranbaxy 

has all discontinued metformin oral 

tablets. 

Mutual discontinued 

all metformin products. 

Teva discontinued metformin unit dose presentations in early-August, 2011. 

UDL discontinued metformin 500 mg 100 unit dose presentation in late-July, 2011. 

Watson discontinued 

d metformin 850 mg and 

1000 mg presentations. 

. 



ashp.org 

Lorazepam injectable presentations 




Lorazepam 2 mg/mL, Akorn 

1 mL vial (NDC 17478-0040-01) 

Lorazepam 2 mg/mL, Bedford 

1 mL vial (NDC 55390-0168-10) 



Lorazepam 4 mg/mL, Bedford 

1 mL vial (NDC 53390-0169-10) 



Lorazepam 2 mg/mL, Hospira 

1 mL iSecure prefilled syringes (NDC 00409-1985-05) - discontinued 

1 mL Carpuject syringes (NDC 00409-1985- 

-30) 

1 mL vial (NDC 00409-6778-02) 

10 mL vials (NDC 00409-6780-02) 

Lorazepam 4 mg/mL, Hospira 

51

1 mL vial (NDC 00409-6779-02) 

10 mL vial (NDC 00409-6781-02) 

1 mL Carpuject syringes (NDC 00409-1539- 

-31) 

Lorazepam 2 mg/mL, West-Ward 

1 mL vial (NDC 10019-0102-01) 

10 mL vial (NDC 10019-0102-10) 


10 mL Novaplus vial 

(NDC 10019-0105-02 

) 

Ativan 2 mg/mL, West-Ward 

1 mL vial (NDC 60977-0112-01) 

10 mL vial (NDC 60977-0116-02) 

Lorazepam 4 mg/mL, West-Ward 

1 mL vial (NDC 10019-0103-01) 


10 mL vial (NDC 10019-0103-10) 


(NDC 10019-0106-02) 

Ativan 4 mg/mL, West-Ward 

1 mL vial (NDC 60977-0113-01) 

10 mL vial (NDC 60977-0113-02) 


Bedford discontinuedd lorazepam in May, 2011 to concentrate on the manufacturing of other 

products. 


Baxter’s lorazepam injection products in May, 2011. The company cannot 

provide a reason for the shortage. 

Hospira states lorazepam vials are on shortage due to increased demand. The 1 mL iSecure 

syringes were discontinued in September 2011. 

Akorn has increased production to help meet 

demand. 



ashp.org 

Granisetron Hydrochloride Injection 




Granisetron Hydrochloride Injection, Akorn 

0.1 mg/mL, 1 mL vial (NDC 17478-0764-02) - discontinued 

1 mg/mL, 1 mL vial (NDC 17478-0546-01) - NDC discontinued 

1 mg/mL, 4 mL vial (NDC 17478-0546-04) - NDC discontinued 

Granisetron Hydrochloride Injection, Apotex 




Granisetron Hydrochloride Injection, APP 

0.1 mg/mL, 1 mL vial (NDC 63323-0317-01) 



Granisetron Hydrochloride Injection, Bedford 


Granisetron Hydrochloride Injection, Sagent 



52


Granisetron Hydrochloride Injection, Teva 




Granisetron Hydrochloride Injection, Wockhardt 



Kytril Injection, Roche 



Akorn discontinued granisetron 0.1 mg/mL 1 mL vials inn August, 2011. NDC codes changed 

for 

the 1 mg/ /mL presentations during this time period as well. 

Apotex, Baxter and Sandoz discontinued their granisetron hydrochloride presentations. 

APP states the shortage is due to manufacturing delays. 

Bedford discontinuedd granisetronn in May, 2011 to concentrate on the 

manufacturing of other 

products. 

Roche discontinued Kytril 0.1 mg/mL and 1 mg/mL 1 mL vials in October, 2009. They 

discontinued the 1 mg/mL 4 mL vials in July 

2010. 

Teva states the shortage is due to 

manufacturing delays. 

Wockhardt discontinued granisetron hydrochloride injection 0.1 mg/ /mL 1 mL vials in early, 

2010. 

Sagent cannot provide a reason for the shortage. 



ashp.org 

Diazepam 

Injectionn 




Diazepam 

injection 5 mg/mL, Hospira 

2 mL Carpuject Luer-Lock syringes, package 

of 10 (NDC 

00409-1273-32) 

2 mL iSecure syringes, package of 10 (NDC 00409-1273-05) 

10 mL vials, package 

of 10 (NDC 

00409-3213-12) 


Hospira has diazepam 

on back order due to manufacturin 

ng delays. 

Hospira is the sole supplier of diazepam injection. 



ashp.org 

Bumetanide Injection 




Bumetanide 0.25 mg/mL, West-Ward 

2mL vial 

(NDC 10019-0506-45) 

Bumetanide 0.25 mg/mL, Bedford 

2 mL vial (NDC 55390-0500-02) 

4 mL vial (NDC 55390-0500-05) 

10 mL vial (NDC 55390-0500-10) 

Bumetanide 0.25 mg/mL, Hospira 

4 mL vial (NDC 00409-1412-04) 

53


10 mL vial (NDC 00409-1412-10) 


(NDC 00409-1412-50) 











Baxter discontinued bumetanide 

0.25 mg/mL 

2 mL vial in early-2011. 


several Baxter products 

including bumetanide in mid-2011. 

Hospira has bumetanide on shortage due to manufacturin 

ng delays. 



ashp.org 

Morphine Injections 




Astramorph (preservative-free) injection, APP 

0.5 mg/mL 2 mL ampule, 10 count (NDC 63323-0291-80) 

0.5 mg/mL 10 mL vial, 5 count (NDC 63323-0291-10) 

1 mg/mL 

2 mL ampule, 10 count 

(NDC 63323-0292-80) 

) 


Morphine injection, West-Ward 







8 mg/mL, 1 mL ampule (NDC 10019-0177-68) - discontinued 

10 mg/mL, 1 mL ampule (NDC 10019-0178-68) - discontinued 

Duramorph (preservative-free), West-Ward 

0.5 mg/mL, 10 mL ampules (NDC 60977-0016-02) 

1 mg/mL, 10 mL ampules (NDC 

60977-0017-01) 

Morphine injection, Hospira 

1 mg/mL 

10 mL amp, package of 5 (NDC 00409-4058-21) - discontinued 

0.5 mg/mL 10 mL, preservative-free vial (NDC 

00409-3815-12) 

1 mg/mL, 30 mL PCA vial (NDC 

00409-2029-02) 

2 mg/mL, 1 mL Carpuject syringe (NDC 00409-1762-30) 

4 mg/mL, 1 mL Carpuject syringe (NDC 00409-1258-30) 

5 mg/mL, 30 mL PCA vial (NDC 

00409-6028-04) 


10 mg/mL, 1 mL Carpuject syringes (NDC 00409-1261- 

-30) 

vial (NDC 00409-3814-12) 

1 mg/mL 

10 mL preservative-free 

25 mg/mL, 1 mL preservative-free vial (NDC 

00409-1135-02) 

25 mg/mL 4 mL Add-Vantage vial (NDC 00409-6177-14) 


APP states the shortage is due to a change in 

manufacturing sites. 


to manufacturing delays. 

54

West-Ward states the 

shortage is due to increased demand for product. 



ashp.org 

Dexamethasone Sodium Phosphate 




Dexamethasone Sodium Phosphate Injection, 4 mg/mL, American Regent 

1 mL single dose vial (NDC 00517-4901-25) 

5 mL multiple dose vial (NDC 00517-4905-25) 

30 mL multiple dose vial (NDC 00517-4930 

-25) 

Dexamethasone Sodium Phosphate Injection, 10 mg/mL, West-Ward 

(formerly Baxter products) 

1 mL vial (NDC 00641-0367-25) 


American 

Regent voluntarily recalled all dexamethasonee sodium phosphate due to the presence 

of particulate matter in the solution and discontinued manufacture off all dexamethasone 4 

mg/mL presentations 

s in March, 2011. 

American 

Regent had 


dexamethasone in April, 2011. 

American 



APP states the dexamethasone sodium phosphate shortage was due to supply and 

demand issues. 

Baxter could not provide a reason 

for the shortage. Baxter sold several products to West-Ward in 

mid-2011. 

Pfizer launched dexamethasone sodium phosphate injection in January, 2012. 



ashp.org 

Epinephrine Metered Dose Inhaler 




Primatene Mist Inhaler (CFC), Armstrong Pharmaceuticals 

0.22 mg/ /actuation, Over-the-Cou 

unter 


To decrease depletion 

of the ozone layer, the 

Food and Drug Administration (FDA) announced 

that epinephrine metered dose inhalers (MDIs) containing chlorofluorocarbon (CFC) propellant 

must be withdrawn from the market by December 31, 2011. 

Other prescription metered dose inhalers such as albuterol were previously transitioned from 

a 

CFC propellant to a hydrofluoroa 

alkane (HFA) propellantt in 2008. 

Armstrong Pharmaceuticals is the only manufacturer of over-the-counter epinephrine inhalers. 

Patients will now need a prescription for any 

type of metered-dose inhaler. Additional 

information for patients is available online. 

Armstrong discontinued Primatene Mist with 

CFC propellant at the end of 2011. The company is 

hoping to 

release a more environmentally friendly Primatene Mist in 

the near future. 



ashp.org 

Trazodone Tablets 




55

Cefaclor 

Suspensionn 




Cefaclor Suspension 125 mg/5 mL, Ranbaxy 

75 mL bottle (NDC 63304-0954- 

-01) 

Trazodone tablets, Mylan 

50 mg, 100 count (NDC 00378-3471-01) 

100 mg, 100 count (NDC 00378-3472-01) 

100 mg, 1000 count (NDC 00378-3472-10) 

Trazodone tablets, Qualitest 

100 mg, 500 count (NDC 00603-6161-28) 

100 mg, 1000 count (NDC 00603-6161-32) 

Trazodone tablets, Teva 

300 mg, 100 count (NDC 00555-0733-02) 


Apotex states the shortage was due to an import ban on this product that was only recently 

removed. Apotex relaunched trazodone tablets in September, 2011. 

Mylan and Qualitest cannot provide a reason 

for the shortage. 



ashp.org 

Nystatin 

Oral Suspension 




Nystatin Oral Suspension, 100,000 units/mL, Qualitest 

60 mL (NDC 00603-1481-49) 

473 mL (NDC 00603-1481-58) 

Nystatin Oral Suspension, 100,000 units/mL, Taro 

60 mL (NDC 51672-4117-04) 

473 mL (NDC 51672-4117-09) 


Fougera and Actavis have discontinued nystatin oral suspension. 

Qualitestt states the reason for the 

shortage is a raw materials shortage. 

Taro and 

PAI could not provide a reason for the shortage. 



ashp.org 

Dextroamphetamine Tablets 




Dextroamphetamine 

tablets, Teva 



-02) 


Teva has 

dextroamphetamine tablets and all other amphetamine products on back order due to a 

raw material shortage. 

Teva is the sole manufacturer of dextroamphetamine tablets. 



ashp.org 

56

150 mL bottle (NDC 

63304-0954-02) 

Cefaclor Suspension 250 mg/ 5 mL, Ranbaxy 

75 mL bottle (NDC 63304-0956- 

-01) 


63304-0956-02) 

Cefaclor Suspension 375 mg/ 5 mL, Ranbaxy 

50 mL bottle (NDC 63304-0957- 

-03) 


63304-0957-04) 


Cefaclor suspension is one of 30 generic products from Ranbaxy that has an FDA 

import ban. 

There are 

no other manufacturers 

of cefaclor 

suspension. . 



ashp.org 

Amphetamine Mixed Salts, Extended-Release Capsules 





salts extended-release capsules, Teva 



00555-0787-02) 


00555-0791-02) 


00555-0788-02) 


00555-0792-02) 


00555-0789-02) 


salts extended-release capsules, Global Pharmaceuticals 



00115-1329-01) 


00115-1330-01) 


00115-1331-01) 


00115-1332-01) 


00115-1333-01) 


Teva cannot provide a reason for 

the shortage. 

Global Pharmaceuticals states the 

shortage is 

due to increased demand. 



ashp.org 

Oxycodone Immediate Releasee Tablets and Capsules 




Immediate Release Tablets 

Oxycodone Immediate-Release Tablets, Qualitest 




-21) 


-28) 


-21) 


-28) 

Immediate Release Capsules 

Oxycodone Immediate-Release Capsules, Mallinckrodt 


57

Oxycodone Immediate-Release Capsules, MidLothian Labs 



Caraco, Mallinckrodt 

t, Qualitest, and Xanodyne could not provide a reason for the shortage. 

Mallinckrodt discontinued their oxycodone immediate-release 5 mg capsules in May, 2011. 



ashp.org 

58

February 2012 Drug Update Information - Pharmacy Benefits ...

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