April 2012 Drug Information Update - Pharmacy Benefits ...

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December 29, 2011. Firm initiated recall is ongoing. REASON Impurities/Degradation Products: Product contains residual by-products of the manufacturing process which were above allowances. PRODUCT (Class II) Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch (NDC 54092-554-01), packaged in 30-count patches per box (NDC 54092- 554-30), Rx only. Recall # D-1259-2012 CODE Lot #: 47313, Exp 07/12; 47937, Exp 08/12; 47955, Exp 09/12 RECALLING FIRM/MANUFACTURER Noven Pharmaceuticals, Inc., Miami FL, by letter dated March 2011. Firm initiated recall is ongoing. REASON Miscalibrated and/or Defective Delivery System: Out of Specification for mechanical peel force and/or the z-statistic. PRODUCT (Class II) Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092- 555-30), Rx only. Recall # D-1260-2012 CODE Lot # 50890, 50894, Exp 12/12 RECALLING FIRM/MANUFACTURER Noven Pharmaceuticals, Inc., Miami, FL, by letter dated September 2011. Firm initiated is ongoing. REASON Miscalibrated and/or Defective Delivery System: Out of Specification for mechanical peel force and/or the z-statistic. PRODUCT (Class II) VALPROIC ACID ORAL SOLUTION, USP, 250 mg/5 mL, 16 fl oz (473 mL), Rx only, NDC 50383-792-16 (Hi-Tech label), and NDC 0591-0426-16 (Watson label). Recall # D-1262-2012 CODE Lot 604482, exp. 1/2013 RECALLING FIRM/MANUFACTURER Hi-Tech Pharmacal Co., Inc., Amityville, NY, by telephone on December 8, 2010 and December 14, 2010, and by letters dated December 8, 2010. Firm initiated recall is ongoing. REASON Failed pH Specification: OOS pH (low) resulted in OOS description for cloudy, hazy, oily appearance of the product. PRODUCT (Class II) Phenylephrine HCl Injection, USP, 1% (10 mg/mL) (50 mg/5 mL), 5 mL Vial, For Pharmacy Use Only, For SC, IM, or IV use, Rx Only, NDC 0517-0405-25. Recall # D-1264-2012 CODE 28
Lot #: 0693, Exp: 10/2012 RECALLING FIRM/MANUFACTURER Luitpold Pharmaceuticals, Inc., Shirley, NY, by press release, email, and/or fax and letter dated February 22, 2012. Firm initiated recall is ongoing. REASON Presence of Particulate Matter: One lot of Phenylephrine HCl Injection, USP, 1%, is being recalled due to the identification of visible particles found in some retain samples of this lot. PRODUCT (Class II) Vidaza (azacitidine for injection), 100 mg Single-Use Vial, for Subcutaneous and Intravenous Use Only, Rx Only, NDC 59572-102-01. Recall # D-1265-2012 CODE Lot numbers for product distributed to the following countries: Japan - Lot #: 100401, Exp. Jun- 14; Switzerland - Lot #: 1345069B, 1345070B, 1345073A, Exp. Dec-11; 1345088A, Exp. Apr- 12; 1859672B, 1599082B, Exp. Apr-13; 1859679A, 1859677A, Exp. Jan-14; Poland - Lot #: 1602514B, Exp. Apr-13; Turkey - Lot #: 1345069A, Exp. Dec-11; 1345088B, 1345088C, Exp. Apr-12; 1859672A, Exp. Dec-13; 1599082A, Exp. Apr-13; 1859677B, Exp. Jan-14; 1859679B, Exp. Feb-14; Hong Kong - Lot #: 1907405, Exp. Mar-14; 1907418, Exp. Jul-14. RECALLING FIRM/MANUFACTURER Recalling Firm: Celgene Corp., Overland Park, KS, by press release on November 22, 2011 and e-mail between November 23/30, 2011. Manufacturer: Ben Venue Laboratories Inc., Bedford, OH. Firm initiated recall is ongoing. REASON Lack of Assurance of Sterility; During an inspection conducted at BVL (the manufacturing firm) by multiple regulatory authorities, including the FDA, manufacturing and quality concerns were identified, including sterility assurance concerns, therefore, this product is being recalled because the manufacturing firm cannot assure sterility of the product. PRODUCT (Class II) Aveeno Baby Calming Comfort Lotion Net Wt. 8 oz. (227 g). Made in Canada, NDC 58232- 0211-1. Recall # D-1266-2012 CODE Lot #0161LK RECALLING FIRM/MANUFACTURER Recalling Firm: Johnson & Johnson, Skillman, NJ, by letter dated January 26, 2012 and press release on January 27, 2012. Manufacturer: Les Emballages Knowlton Inc., Knowlton, Canada. Firm initiated recall is ongoing. REASON Microbial Contamination of Non-Sterile Products: Product recall due to a potential for microbial (coagulase negative staphylococci) contamination. PRODUCT (Class II) Flutamide Capsules USP, 125 mg, Rx Only, 180-count bottle, NDC 0172-4960-58. Recall # D- 1267-2012 CODE Lot #s: J05761, Exp 11/2012; J15067, Exp 1/2013; J15229, Exp 4/2013 29
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: PRODUCT (Class II) 1) Ventolin HFA
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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