April 2012 Drug Information Update - Pharmacy Benefits ...

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14) Excedrin PM (acetaminophen 500 mg and diphenhydramine citrate 38 mg) Express Gels gelcaps, packaged in a) 20-ct. bottles (NDC 0067-6405-20); and b) 80-ct. bottles (NDC 0067- 6405-80 and NDC 0067-6409-80). Recall # D-1240-2012; 15) Excedrin PM (acetaminophen 500 mg and diphenhydramine citrate 38 mg) tablets, packaged in a) 8-ct. bottles (NDC 0067-2053-08); b) 24-ct. bottles (NDC 0067-2053-24); c) 30-ct. bottles (24-ct. + 6-ct. bonus) (NDC 0067-2053-30); d) 50-ct. bottles (NDC 0067-2053-50); e) 100-ct. bottles (NDC 0067-2053-91 and NDC 0067-2053-94); f) 125-ct. (100-ct. + 25-ct. bonus) (NDC 0067-2053-83). Recall # D-1241-2012; 16) Excedrin Sinus Headache (acetaminophen 325 mg and phenylephrine HCl 5 mg) caplets, 24- ct. bottles; NDC 0067-2062-24. Recall # D-1242-2012; 17) Excedrin Tension Headache (acetaminophen 500 mg and caffeine 65 mg) caplets, packaged in a) 24-ct. bottles (NDC 0067-2045-24); b) 30-ct. (24-ct. + 6-ct. bonus) (NDC 0067-2045-30); c) 50-ct. bottles (NDC 0067-2045-50); d) 100-ct. bottles (NDC 0067-2045-91 and NDC 0067- 2045-94); e) 125-ct. bottles (100-ct. + 25-ct. bonus) (NDC 0067-2045-83 and NDC 0067-2045- 84); and f) 250-ct. bottles (NDC 0067-2045-77 and NDC 0067-2045-07). Recall # D-1243-2012; 18) Excedrin Tension Headache (acetaminophen 500 mg and caffeine 65 mg) Express Gels gelcaps, packaged in a) 20-ct. bottles (NDC 0067-6272-20); b) 40-ct. bottles (NDC 0067-6272- 40); and c) 80-ct. bottles (NDC 0067-6272-94). Recall # D-1244-2012; 19) Excedrin Tension Headache (acetaminophen 500 mg and caffeine 65 mg) geltabs, 24-ct. bottles; NDC 0067-2050-24. Recall # D-1245-2012; 20) Gas-X Prevention [alpha-galactosidase enzyme (aspergillus niger)] capsules, 600 GALU, packaged in a) 20-ct. bottles (UPC 30043-3005-208) and b) 50-ct. bottles (UPC 30043-3005- 505). Recall # D-1246-2012; 21) Maximum Strength NoDoz (caffeine) coated caplets, 200 mg, packaged in a) 16-ct. bottles (NDC 0067-2070-16); b) 36-ct. bottles (NDC 0067-2070-36); and c) 60-ct. bottles (NDC 0067- 2070-60). Recall # D-1247-2012 CODE All lots that bear expiration date of 12/20/13 or earlier and all lots that bear expiration date of 12/20/14 or earlier. RECALLING FIRM/MANUFACTURER Novartis Consumer Health, Lincoln, NB, by press release, telephone and letters on January 8, 2012 and letters on January 9, 2012. Firm initiated recall is ongoing. REASON CGMP Deviations: Potential for the bottles to contain foreign tablets or broken/chipped tablets; lack of cGMP's. PRODUCT (Class II) 1) Cefprozil Powder for Oral Suspension, USP 125 mg/5 mL when constituted according to direction, Rx only, 100 mL. NDC: 00781-6202-46. Recall # D-1249-2012 2) Cefprozil Powder for Oral Suspension, USP 250 mg/5 mL when constituted according to direction, Rx only, 100 mL. NDC: 00781-6203-46. Recall # D-1250-2012 CODE 1) Lots BX3481 and BX3483 and 2) Lot: BX3670 RECALLING FIRM/MANUFACTURER Recalling Firm: Sandoz Inc., Broomfield, CO, by letter dated January 2012. Manufacturer: Sandoz GmbH, Kundl, Austria. Firm initiated recall is ongoing. REASON CGMP Deviations: Batches lack manufacturing validation. 26
PRODUCT (Class II) 1) Ventolin HFA (albuterol sulfate) 90 mcg per actuation a) 60 Actuations, NDC 0173-0682-21; b) 60 Actuations Sample, NDC 0173-0682-23; c) 60 Actuations Institutional Pack, NDC 0173- 0682-24 Rx only. Recall # D-1252-2012; 2) Ventolin HFA Inhaler (albuterol sulfate) 90 mcg per actuation NOVAPLUS - 60 Actuations, Rx only, NDC 0173-0682-54. Recall # D-1253-2012 CODE 1) Lot: 1ZP0922, 1ZP0571, 1ZP6915, 1ZP6939, 1ZP7823, 1ZP8151, 1ZP0856, 1ZP1981, 1ZP6941, 1ZP7824, 1ZP9063; 2)Lot numbers: 1ZP1061, 1ZP6940 and 1ZP9680 RECALLING FIRM/MANUFACTURER GlaxoSmithKline Inc., Zebulon, NC, via letter on/about January 18, 2012. Firm initiated recall is ongoing. REASON Does Not Deliver Proper Metered Dose: The affected canisters may not contain sufficient propellant to deliver the labeled claim of 60 doses. PRODUCT (Class II) Cytarabine for Injection USP, for Intravenous, Subcutaneous, or Intrathecal use, 1 gram, Rx Only, NDC 55390-133-01. Recall # D-1255-2012 CODE Lot #: 2066986, Exp 03/31/2014; 2111675, Exp 04/30/2014; 2131148, Exp 05/31/2014 RECALLING FIRM/MANUFACTURER Ben Venue Laboratories Inc., Bedford, OH, by letter on February 15, 2012, a press release on February 16, 2012 and a follow-up letter on February 17, 2012. Firm initiated recall is ongoing. REASON Lack of Assurance of Sterility PRODUCT (Class II) 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx only, NDC 0409-7972-08. Recall # D- 1257-2012 CODE Lot Code: 09-060-JT RECALLING FIRM/MANUFACTURER Hospira, Inc., Austin, TX, by letters on February 13, 2012. Firm initiated recall is ongoing. REASON Lack of Assurance of Sterility: there is a potential for solution to leak from the administration port of the primary container. PRODUCT (Class II) Fludeoxyglucose F18 Injection, multiple-dose glass vial containing 0.74 - 11.1 GBq (20 - 300 mCi/mL), and labeled in part ***Sterile Non-pyrogenic***Radioactive. Recall # D-1258-2012 CODE Lot 6509, Exp 6:15 pm on 27 Dec 2011 RECALLING FIRM/MANUFACTURER Precision Nuclear of Virginia, Salem, VA, by telephone on December 27, 2011 and by letter on 27
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 and 20: finding that it also may reduce the
Page 21 and 22: Syringes (2 mL size), Rx only. NDC
Page 23 and 24: Patheon Pharmaceuticals Inc., Cinci
Page 25: 50-ct. bottles (NDC 0067-6238-50);
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
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