April 2012 Drug Information Update - Pharmacy Benefits ...

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089-50), b) 100 Caplets (NDC 63868-089-01); 5) Select Brand Arthritis Pain Relief (Acetaminophen 650mg), a) 100 Caplets (NDC 15127-530- 01) b) 24 Caplets (NDC 15127-530-24), c) 50 Caplets (NDC 15127-530-50); 6) Premier Value Arthritis Pain Relief (Acetaminophen 650mg), a) 50 Caplets (NDC 68019-019- 45), b) 100 Caplets (NDC 68016-021-06). Recall # D-1211-2012 CODE 1) Lot # 10J745, Exp Date Sep-12; Lot # 10J746, Exp Date Sep-12; Lot # 10J747, Exp Date Sep- 12; Lot # 10K798, Exp Date Oct-12; Lot # 10K814, Exp Date Oct-12; Lot # 10K814, Exp Date Oct-12; Lot # 10K799, Exp Date Oct-12; Lot # 10K816, Exp Date Oct-12; Lot # 10K861, Exp Date Oct-12; Lot # 10L861, Exp Date Nov-12; Lot # 10L862, Exp Date Nov-12; Lot # 10L862, Exp Date Nov-12; Lot # 10L863, Exp Date Nov-12; Lot # 10L891, Exp Date Nov-12; Lot # 10L890, Exp Date Nov-12; Lot # 11A004, Exp Date Jan-13; Lot # 11A004, Exp Date Jan-13; Lot # 11A062, Exp Date Jan-13; Lot # 11A061, Exp Date Jan-13; Lot # 11A062, Exp Date Jan- 13; Lot # 11A062, Exp Date Jan-13 & Lot # 11G481, Exp Date Jul-13; 2) Lot # 10L889, Exp Date Nov-12; Lot # 10L890, Exp Date Nov-12; and Lot # 10L863, Exp Date Nov-12; Lot # 10L889, Exp Date Nov-12 & Lot # 11A062, Exp Date Jan-13; 3) Lot # 10K799, Exp Date Oct-12; Lot # 10L863, Exp Date Nov-12; Lot #, 11A061, Exp Date, Jan-13 & Lot # 11A062, Exp Date Jan-13; 4) Lot # 11A004, Exp Date Jan-13; Lot # 11A060, Exp Date Jan-13; Lot # 11H484, Exp Date Jul-13 & NDC 63868-089-50, Lot # 11A004, Exp Date Jan-13; 5) Lot # 10K816, Exp Date Oct-12; Lot #, 10L863, Exp Date, Nov-12; Lot # 11A004, Exp Date Jan-13; NDC 15127-530-24, Lot # 10K814, Exp Date Oct-12; Lot # 11A004, Exp Date Jan-13; Lot # 11A062, Exp Date Jan-13; Lot # 10K814, Exp Date Oct-12; Lot # 11A004, Exp Date Jan- 13 & Lot # 11A062, Exp Date, Jan-13; 6) All Lots RECALLING FIRM/MANUFACTURER Recalling Firm: Aphena Pharma Solutions LLC, Glasgow, KY, by letters on December 2, 2011. Manufacturer: Advance Pharmaceutical Inc., Ronkonkoma, NY. Firm initiated recall is ongoing. REASON Marketed without an approved NDA/ANDA: The recall is due to incorrect dosage information indicated on the primary bottle and the outside carton labeling. The labeling contained the following information: take 2 caplets every 8 hours with water. This labeling exceeds the allowable monograph quantity of acetaminophen in an 8 hour period. PRODUCT (Class II) 1) DynaCirc CR (isradipine) Controlled Release Tablets, 5 mg, 30-count bottles, Rx only; NDC 0173-0784-01; UPC 3 0173-0784-01 8. Recall # D-1212-2012; 2) DynaCirc CR (isradipine) Controlled Release Tablets, 10 mg, 30-count bottles, Rx only; NDC 0173-0785-01, UPC 3 0173-0785-01 5. Recall # D-1213-2012 CODE 1) Lot #: 10084536, Exp 12/12; 10102915, Exp 03/13; 10102916, Exp 06/13; 10107157, Exp 07/13; and 10108172, Exp 09/13; 2) Lot #: 10087732, Exp 01/13; 10091069, 10094639; Exp 03/13; 10102913, Exp 07/13; and 10109327, Exp 10/13 RECALLING FIRM/MANUFACTURER Recalling Firm: GlaxoSmithKline Inc., Zebulon, NC, by letter dated February 3, 2012. Manufacturers: Novartis Consumer Health, Lincoln NB; 22
Patheon Pharmaceuticals Inc., Cincinnati, OH. Firm initiated recall is ongoing. REASON CGMP Deviations: These lots are being recalled due to compliance concerns regarding the level of cGMP compliance and procedural controls related to line clearance during the packaging process at the Novartis Consumer Health, site. PRODUCT (Class II) 1) Female One Series Vagifresh Moisturizing Gel, 2 fl. oz. (59mL) carton, Made in U.S.A. UPC Code: 689076499057. Recall # D-1214-2012; 2) Female One Series Vagifresh Ball, 3 tablets per carton, UPC Code: 689076499156. Recall # D-1215-2012 CODE All Lots. RECALLING FIRM/MANUFACTURER Recalling Firm: U.S.A Far Ocean Group LLC, Alhambra, CA, by press was release on January 18, 2012 and by letter on January 25, 2012. Manufacturer: Essential Pharmaceutical Corp, Pomona, CA. Firm initiated recall is ongoing. REASON 1) Labeling: Product contains Undeclared Active Ingredient; The recall was initiated because Far Ocean Group has confirmed that the Vagifresh Gel contains Benzocaine, an active ingredient for many anesthetic drug products. 2) Microbial Contamination of Non-Sterile Products; Far Ocean Group and FDA lab analysis confirmed that the Vagifresh Ball contains bacteria that may be a potential health risk. PRODUCT (Class II) Quelicin 1000, Succinylcholine Chloride, Inj., USP, 10mL single dose in 20mL Fliptop Vials, Rx only, NDC 0409-6970-10. Recall # D-1218-2012 CODE Lot number: 02-575-EV RECALLING FIRM/MANUFACTURER Recalling Firm: Hospira, Inc., Lake Forest, IL, by letter on January 17, 2012. Manufacturer: Hospira, Inc., Rocky Mount, NC. Firm initiated recall is ongoing. REASON Labeling: Correct Labeled Product Mispacked; a vial of Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, USP, 20 mL Fliptop Vial was found inside a 25 pack of Quelicin 1000. PRODUCT (Class II) 1) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) Tablets, packaged in a) 100-count bottles (NDC 0067-2030-91), b) 250-count bottles (NDC 0067-2030-77), and c) 300-count bottles (NDC 0067-2030-33). Recall # D-1220-2012; 2) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) Express Gels gelcaps, packaged in 80-count Gelcaps per bottle, NDC 0067-6270-94. Recall # D- 1221-2012; 3) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) Caplets, packaged in 24-count bottles, NJ 07054-0622, NDC 0067-2039-24. Recall # D-1222- 2012; 23
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: Syringes (2 mL size), Rx only. NDC
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
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