April 2012 Drug Information Update - Pharmacy Benefits ...

More documents

Recommendations

Info

Merck Blood Thinner Stops Heart Attacks With Risk of Bleeding March 28, 2012 A study of an experimental blood thinner from Merck & Co. showed that while the drug helped thwart heart attacks it raised the risk of brain bleeding, a side effect that could stymie its approval. The three-year study of 26,449 patients who had heart attack, stroke or leg artery disease, found those who got Merck’s vorapaxar along with standard therapy were 13 percent less likely to have another heart attack or die from cardiovascular causes than those on standard treatment. More patients on the drug also had serious bleeding, according to data reported today at the American College of Cardiology meeting in Chicago. Article link: http://www.bloomberg.com/news/2012-03-24/merck-blood-thinner-stopsheartattacks-with-risk-of-bleeding.html Source website: http://www.bloomberg.com/ Recalls PRODUCT (Class I) Excedrin Tension Headache (acetaminophen 500 mg, caffeine 65 mg) Caplets, packaged in a) 100-count bottles (NDC 0067-2045-91), b) 125-count bottles (NDC 0067-2045-84), c) 250-count bottles (NDC 0067-2045-07). Recall # D-1219-2012 CODE Lot #: a) 10087530, Exp. 3/31/2013; b) 10089902, Exp. 4/30/2013; c) 10063947, Exp. 11/30/2011 RECALLING FIRM/MANUFACTURER Novartis Consumer Health, Lincoln, NB, by letters on October 31, 2011 and press release on January 8, 2012. Firm initiated recall is ongoing. REASON Adulterated Presence of Foreign Tablets: Consumer complaints of foreign tablets reported in the products. PRODUCT (Class I) Treanda (bendamustine HCL) for injection, 25mg/vial, Sterile-Single Use Vial, Rx Only, NDC 63459-0390-08. Recall # D-1254-2012 CODE Lot #: TB30111, Exp 12/2012 RECALLING FIRM/MANUFACTURER Recalling Firm: Cephalon, Inc., Malvern, PA, by letter on November 18, 2011 and press release on January 27, 2012. Manufacturer: Pharmachemie B.V., Haarlem, Netherlands. Firm initiated recall is ongoing. REASON Presence of Particulate Matter; Glass fragments have been reported in a single vial. PRODUCT (Class II) 1) Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension), 1,200,000 units per 2 mL, Ten Syringes (2 mL size), Rx only. NDC 60793-600-10. Recall # D- 1204-2012 2) Bicillin L-A (penicillin G benzathine injectable suspension), 1,200,000 units per 2 mL, Ten 20
Syringes (2 mL size), Rx only. NDC 60793-701-10. Recall # D-1205-2012; 3) GONAL- f RFF Pen (follitropin alfa injection) 900 IU/1.5 mL, For Subcutaneous injection, Rx only, NDC 44087-1114-1. Recall # D-1206-2012; 4) PULMOZYME (DORNASE ALFA) INHALATION SOLUTION, 30 Ampules, NDC 50242- 100-40. Recall # D-1207-2012; 5) Rebif (Interferon beta-1a) 44 mcg/0.5 mL, 12 Single-use prefilled syringes, NDC 44087- 0044-3. Recall # D-1208-2012; 6) VSL #3 DS (DOUBLE STRENGTH), 20 SACHETS, Prescription only, Product Code 45749- 017-82, NDC 45749-017-82, Recall # D-1209-2012 CODE 1) Lot #: 60746; 2) Lot #: 61331; 3) Lot #: BA002807; 4) Lot #: 867896; 5) Lot #: AU000878; 6) Lot #: 2448A11 RECALLING FIRM/MANUFACTURER Recalling Firm: Kinray Inc., Whitestone, NY, by telephone on June 15, 2011 and by e-mail and fax on June 24, 2011. Manufacturers: King Pharmaceuticals a wholly owned subsidiary of Pfizer, Bristol, TN; Genentech Inc., South San Francisco, CA. Firm initiated recall is complete. REASON Temp Abuse: Kinray Inc. is recalling these products because a refrigeration unit at their distribution facility malfunctioned, causing the temperature to rise above the storage specification. PRODUCT (Class II) OFIRMEV, (acetaminophen) injection, 1000 mg/100 mL, (10 mg/mL, For Intravenous Use Only, Rx Only, NDC 43825-102-01, is supplied in a 100mL glass vial, containing 1000mg acetaminophen (10mg/mL) OFIRMEV (acetaminophen), NDC 43825-102-01. Recall # D-1210- 2012 CODE Lot V005710, Exp. 05/12 RECALLING FIRM/MANUFACTURER Recalling Firm: Cadence Pharmaceuticals, San Diego, CA, by press release and letters on February 6, 2012. Manufacturer: Baxter Healthcare Corp, Cleveland, MS. Firm initiated recall is ongoing. REASON Presence of Particulate Matter: An unidentified visible particle was found in one vial during routine stability testing. PRODUCT (Class II) 1) Assured Pain Relief for Arthritis, (Acetaminophen 650mg), 24 Caplets (NDC 45738-717-24); 2) Consumer's Choice Pain Relief for Arthritis, (Acetaminophen 650mg), a) 100 Caplets (NDC 45738-715-10), b) 24 Caplets (NDC 45738-715-24); 3) Preferred plus Acetaminophen for Arthritis (Acetaminophen 650mg), 100 Caplets (NDC 45738-716-10); 4) Quality Choice Arthritis Pain Relief (Acetaminophen 650mg), a) 50 Caplets (NDC 63868- 21
Page 1 and 2: April 2012 Drug Information Update
Page 3 and 4: First-Time Generics GENERIC DRUG NA
Page 5 and 6: GENERAL ANESTHETICS, INJECTABLE MID
Page 7 and 8: Gruenhaupt, Mark R.Ph. Argus Health
Page 9 and 10: Statin Drugs - Drug Safety Communic
Page 11 and 12: Vytorin (ezetimibe/simvastatin) Tab
Page 13 and 14: low blood sugar (hypoglycemia) in p
Page 15 and 16: Some women with depression who beco
Page 17 and 18: Survival increased for all groups o
Page 19: finding that it also may reduce the
Page 23 and 24: Patheon Pharmaceuticals Inc., Cinci
Page 25 and 26: 50-ct. bottles (NDC 0067-6238-50);
Page 27 and 28: PRODUCT (Class II) 1) Ventolin HFA
Page 29 and 30: Lot #: 0693, Exp: 10/2012 RECALLING
Page 31 and 32: 24 (Display case UPC# 3030045074923
Page 33 and 34: CODE Lot # 139961 RECALLING FIRM/MA
Page 35 and 36: Reason for the Shortage • Teva co
Page 37 and 38: Reason for the Shortage • Ben Ven
Page 39 and 40: Products Affected - Description Gan
Page 41 and 42: 37.5 mg/25 mg, 1000 count (NDC 0078
Page 43 and 44: Acyclovir tablets, Major 400 tablet
Page 45 and 46: 500 mg, 100 count (NDC 63304-0726-0
Page 47 and 48: 750 mg tablets, 100 count (NDC 1013
Page 49 and 50: • Bedford Laboratories has multip
Page 51 and 52: Daunorubicin Hydrochloride Injectio
Page 53 and 54: Ciprofloxacin Immediate-Release Tab
Page 55 and 56: • APP had tobramycin 40 mg/mL pre
Page 57 and 58: • Ben Venue voluntarily suspended
Page 59 and 60: 50 mg/mL, 10 mL vial, package of 10
Page 61 and 62: 2 mL vial, preservative-free (NDC 6
Page 63 and 64: 5 mg single dose vial, package of 1
Page 65 and 66: 20 mL glass ampule, sterile pack (N
Page 67 and 68: 2 mL iSecure syringe (NDC 00406-112
Page 69 and 70: Lidocaine 0.5% Xylocaine 0.5% injec
Page 71 and 72:
• Teva discontinued all ciproflox
Page 73 and 74:
Nicardipine hydrochloride injection
Page 75 and 76:
Article link: http://www.ashp.org/D
Page 77 and 78:
• Apotex had metformin products u
Page 79:
• Covis purchased all rights to F
show all

April 2012 Drug Information Update - Pharmacy Benefits ...

Create successful ePaper yourself

Delete template?

Save as template?