April 2012 Drug Information Update - Pharmacy Benefits ...

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PRODUCT (Class III) Azelastine Hydrochloride Ophthalmic Solution, 0.05% 6 mL-Sterile, For the Eye Only, Rx only, NDC 47335-938-90. Recall # D-1251-2012 CODE Lots: JKJl389A, JKJ1514A JKJ1515A. JKJ2541A, JKJ2542A, JKJ2646A, JKJ3050A, JKJ3425A, JKJ3126A, JKK0817A, JKK0884A, JKK0885A, JKJ2187A, JKK2268A, JKK2269A, JKK2315A, JKK2472A, JKK2473A RECALLING FIRM/MANUFACTURER Sun Pharmaceutical Industries Ltd., Halol, India, by letters and telephone beginning February 6, 2012. Firm initiated recall is ongoing. REASON Impurities/Degradation Products: The total impurities results were out of specification (OOS) during the analysis of 18 month controlled stability sample PRODUCT (Class III) Gentamicin Sulfate in 0.9% Sodium Chloride Injection, 80 mg in 50 mL single dose VIAFLEX Plus Container, NDC 0338-0509-41. Recall # D-1256-2012 CODE Lot #: P266742, Exp. 10/12 RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated February 17, 2012, Manufacturer: Baxter Healthcare Corp., Jayuya, PR. Firm initiated recall is ongoing. REASON Subpotent (Single Ingredient) Drug: An analytical calculation error resulted in the release of a lot of finished product Isotonic Gentamicin Sulfate Injection that was 2% below the approved concentration range. PRODUCT (Class III) Cervidil (Dinoprostone) 10 mg Vaginal Insert; supplied in boxes of 6, Rx only, NDC 0456-4123- 63, Item #194-2242. Recall # D-1261-2012 CODE Lot numbers: MA09D05B, MA09H04B, MA09W02B, MA09N06B, MA09K01B, MA09K07B, MA09F08B, MA09F10B, MA09P05B, MA09R01B, MA09R07B, MA10D02B, MA10D03B, MA10W07B, MA10N05B, MA10N07B, MA10Q07B, MA10Q09B, MA10K07B, MA10K06B, MA10X06B, MA10F05B, MA10F06B, MA10R03B, MA10R04B, MA10B07B, MA11D06B, MA11W04B, MA11N05B, MA11Q02B, MA11Q08B, MA11K05B, MA11X03B, MA11K03B, MA08P02B and MA11W05B. RECALLING FIRM/MANUFACTURER Recall Firm: H D Smith Wholesale Drug Co., Springfield, IL, by telephone and e-mails the weekend of January 28-29, 2012, and by letter on February 2, 2012. Manufacturer: Controlled Therapeutics, Ltd., East Kilbride, UK. Firm initiated recall is ongoing. REASON Temperature Abuse; product not stored at labeled temperature. PRODUCT (Class III) Brimonidine Tartrate Ophthalmic Solution 0.2% (Sterile), Each mL Contains Active: Brimonidine tartrate 0.2% (Sterile), 15 mL bottles, Rx only, NDC 24208-411-15. Recall # D- 1263-2012 32
CODE Lot # 139961 RECALLING FIRM/MANUFACTURER Bausch & Lomb, Inc., Tampa, FL, by letters on February 22, 2012. Firm initiated recall is ongoing. REASON Impurity/Degradation; 9 month stability. PRODUCT (Class III) 1) Squibb Kenalog Injection 10 (Triamcinolone Acetonide Injectable Suspension, USP), 50 mg/5 mL, 10 mg/mL, 5 mL multiple vial, Rx only, NDC 0003-0494-20. Strength Product/SAP Package/I Description NDC Expiration No. 10 mg/mL KENALOG SINJ 10MG/ML (1VL.X5ML) US 0003-0494-20 SEPT 2012. Recall # D-1269-2012; 2) Squibb Kenalog Injection 40 (Triamcinolone Acetonide Injectable Suspension, USP), 40 mg/mL, 10 mL multiple vial, Rx only, NDC 0003-0293-28, Strength Lot Number Product/SAP Package/I Description NDC Expiration No. 40 mg/mL KENALOG SINJ 40MG/ML (1VL.X5ML) US 0003-0293-20 SEPT 2012,, 40 mg/mL KENALOG SINJ 40MG/ML (1VL.X10ML) US 0003-0293-28 OCT 2012, 40 mg/mL KENALOG SINJ 40MG/ML (1VL.X10ML) US 0003-0293-28 OCT 2012, 40 mg/mL KENALOG SINJ 40MG/ML (1VL.X10ML) US 0003-0293-28 OCT 2012, 40mg/mL KENALOG SINJ 40MG/ML (1VLX10ML) US 0003-0293-28 OCT 2012. Recall #D-1270-2012 CODE 1) OK65465 1131273; 2) OK66391 1131271; OK66412 1131272, OK66414 1131272, OK66501 1131272, OL56792 1131272 RECALLING FIRM/MANUFACTURER Bristol-Myers Squibb, Anagni, Italy, by letters dated October 21, 2011 and December 14, 2011. Firm initiated recall is ongoing. REASON Presence of Precipitate: Atypical particle size found in vial. PRODUCT (Class III) 1) Enoxaparin Sodium Injection, USP, 100 mg/mL, 1 mL pre-filled Single Dose Syringe in a blister (NDC 0781-3500-05) packaged in 10-count Syringes in a blister per carton (NDC 0781- 3500-69), Rx Only. Recall # D-1274-2012; 2) Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, 0.3 mL pre-filled Single Dose Syringe in a blister, NDC 0781-3133-01, packaged in 10-count Syringes in a blister per carton, NDC 0781- 3133-63, Rx Only. Recall # D-1275-2012 CODE 1) Lot #: 917713, Exp 08/13; 2) Lot #: 917995, Exp 08/13 RECALLING FIRM/MANUFACTURER Recalling Firm: Sandoz Inc., Broomfield, CO, by letters on February 13, 2012. Manufacturer: Baxter Pharmaceuticals Solutions, LLC, Bloomington, IN. Firm initiated recall is ongoing. REASON Defective Container: Small defects with stopper ribs. 33
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 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: 24 (Display case UPC# 3030045074923
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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