June 2012 Drug Information Update - Pharmacy Benefits ...

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with an incorrect expiry date, past the recommended shelf life from the date of manufacture. PRODUCT (Class II) 1) Topiramate Tablets, 100 mg, a) 60-count tablets per bottle (NDC 0093-7219-06, UPC 3 0093- 7219-06 4), b) 1000-count tablets per bottle (NDC 0093-7219-10, UPC 3 0093-7219-10 1), Rx only. Recall # D-1339-2012; 2) Topiramate Tablets, 50 mg, 1000-count tablets per bottle, Rx only, NDC 0093-7540-10, UPC 3 0093-7540-10 6. Recall # D-1340-2013; 3) Topiramate Tablets, 200 mg, 1000-count tablets per bottle, Rx only, NDC 0093-7220-10, UPC 3 0093-7220-10 7. Recall # D-1341-2012 CODE 1) Lot #: a) 29T097, 29T098, Exp 08/13; b) 29T093, 29T094, 29T096, Exp 07/13; 29T099, Exp 08/13; 2) Lot #: 16T023, 16T024, and 16T026, Exp 03/12; 3) Lot #: 30T044, Exp 06/12; and 30T085, Exp 07/13 RECALLING FIRM/MANUFACTURER Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on March 28, 2012. Manufacturer: Teva Pharmaceutical Industries Ltd., Jerusalem, Israel. Firm initiated recall is ongoing. REASON Impurities/Degradation Products: The specified lots may not meet the impurity specification through expiry PRODUCT (Class II) Ovcon 50 (norethindrone and ethinyl estradiol) tablets, USP, 1 mg/50 mcg, a) 3-count blister cards of 28 tablets each per carton (NDC 0430-0585-45, UPC 3 0430-0585-45 9), b) 6-count blister cards of 28 tablets each per Physician's Sample carton (NDC 0430-0585-95), Rx only. Recall # D-1344-2012 CODE Lot #: a) 506964B, Exp 05/12; 509310A, Exp 09/12; 511071A, Exp 12/12; b) 506964C, Exp 05/12 RECALLING FIRM/MANUFACTURER Warner Chilcott Company LLC, Fajardo, PR, by letter dated April 3, 2012. Firm initiated recall is ongoing REASON CGMP Deviations: This recall is being initiated as part of the commitments to the response to the FDA concerns on lack of full shelf-life stability data supporting 12-months expiry date. PRODUCT (Class II) Product is single dose vials of hepatitis B vaccine. Labeling reads in part: "***ENGERIX-B 20 mcg/mL NDC 58160-821-01***EACH mL CONTAINS 20 mcg OF HEPATITIS B SURFACE ANTIGEN ADSORBED ON 0.5 mg ALUMINUM AS ALUMINUM HYDROXIDE***STORE AT 36 - 46 F. SEE USP. DO NOT FREEZE***DIST. BY: GLAXOSMITHKLINE RESEARCH TRIANGLE PARK, NC 27709 PRODUCT ID: CLEAR GLASS VIAL WHITE/BLACK/ORANGE/TEAL LABEL***NDC 58160-821-01***DISCARD IF FROZEN. Recall # B-1088-12 CODE 28
NDC 5816082101 (single dose vial); NDC 5816082111 (box of 10 vials). RECALLING FIRM/MANUFACTURER Recalling Firm: Normed, Seattle, WA, by letters beginning June 16, 2011. Manufacturer: Glaxo Smithkline – Rixensart, Rixensart, Belgium. FDA initiated recall is ongoing. REASON Engerix-B, lacking assurance of proper storage temperatures, was distributed. PRODUCT (Class II) Celestone brand of betamethasone Oral Solution USP, 0.6 mg/ 5 mL, supplied in 4 fluid ounce (118 mL) amber glass bottles, Rx only, NDC 0085-0942-05. Recall # D-1354-2012 CODE LOT 9 APR, 100 EXP MAR 12; LOT 9 APR 101, EXP AUG 12; LOT 9 APR 102, EXP SEP 12; LOT 9 APR 103, EXP NOV 12; LOT 0 APR 100, EXP MAR 13; LOT 0 APR 101, EXP JUN 13; LOT 0 APR 102, EXP SEP 13; LOT 0 APR 103, EXP SEP 13 RECALLING FIRM/MANUFACTURER Merck, Inc., Kenilworth, NJ, by letters on January 23, 2012. Firm initiated recall is ongoing. REASON Failed Content Uniformity Requirements; potential for dosing variability found during routine product stability testing. PRODUCT (Class III) 1) buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, packaged in a) 30-count tablets per bottle (NDC 67767-142-30), b) 90-count tablets per bottle (NDC 67767-142-90), c) 500-count tablets per bottle (NDC 67767-142-05), Rx only. Recall # D-1328-2012; 2) buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, packaged in a) 30-count tablets per bottle (NDC 67767-141-30), b) 90-count tablets per bottle (NDC 67767-141-90), Rx only. Recall # D-1329-2012 CODE 1) Lot #: a) 759C11, 760C11, 761C11; Exp 01/12; CE0D06A, CE0D07A, CE0D08A, Exp 04/12; 482K01, CH0D20A, CH0D23A, CH0D25A, CH0D28A, CH0D31A, Exp 07/12; 244K01, 546K01, 547K01, 553K01, CJ0D05A, CJ0D12A, CJ0D13A, CJ0D14A, CJ0D15A, CJ0D18A, Exp 08/12; 332A11, Exp 12/12; b) CE0D09A, Exp 04/12; 481K01, Exp 07/12; 243K01, 545K01, CJ0D09A, CJ0D11A, Exp 08/12; 248M01, 330A11, Exp 11/12; 333A11, Exp 12/12; c) CE0D10A, CE0D11A, CE0D12A, Exp 04/12; CH0D16B, CH0D17B, CH0D18A, CH0D19A, CH0D21A, CH0D22A, CH0D24A, CH0D29A, CH0D30A, Exp 07/12; 245K01, Exp 08/12, CJ0D23A, CJ0D24A, Exp 09/12; 2) Lot #: a) 549K01, 584K01, 644L01, 645L01 646L01, 647L01 648L01, CK0D12A, CK0D13A, CK0D14A, CK0D15A, CK0D16A, CK0D17A, Exp 01/12; CL0D03A, CL0D04A, Exp 02/12; 303M01, Exp 03/12; 476B11, 477B11, 478B11, 479B11, 570B11, 571B11, Exp 04/12; CF0D01A, CF0D02A, CF0D05A, CF0D21A, CF0D22A, Exp 05/12; CG0D07A, CG0D08A, CG0D09A, CG0D12A, CG0D26A, Exp 06/12; CG1D10A, Exp 10/12; 550K01, 551K01, 552K01, Exp 11/12; b) 548K01, CK0D18A, CK0D19A, CK0D20A, Exp 01/12; CL0D01A, CL0D02A, Exp 02/12; 228A11, 229A11, 272M01, 273M01 304M02, CD0D15A, CM0D02A, Exp 03/12; 526B11, 553B11, Exp 04/12; CF0D06A, CF0D07A, CF0D08A, CF0D23A, CF0D24A, Exp 05/12; CG0D01A, CG0D02A, CG0D03A, CG0D04A, CG0D05A, CG0D06A, CG0D10A, CG0D11A, CG0D25A, CG0D27A, CG0D28A; 06/12; CH0D01A, 29
Page 1 and 2: June 2012 Drug Information Update
Page 3 and 4: First-Time Generics GENERIC DRUG NA
Page 5 and 6: ANTI-DIARRHEALS OPIUM TINCTURE DISP
Page 7 and 8: indicated for the treatment of HIV-
Page 9 and 10: Source website: http://www.fda.gov/
Page 11 and 12: Testosterone Chases Viagra in Libid
Page 13 and 14: Analytical Trend Troubles Scientist
Page 15 and 16: Testosterone supplements may help m
Page 17 and 18: voted 19-3 to endorse the drug's us
Page 19 and 20: New Drug Trial Seeks to Stop Alzhei
Page 21 and 22: translates into a 38 percent reduct
Page 23 and 24: atypical fractures of the thigh bon
Page 25 and 26: contain Sibutramine, an appetite su
Page 27: 2 fl oz UPC 011673257424. Recall #
Page 31 and 32: Manufacturer: Catalent Argentina S.
Page 33 and 34: • Fera cannot provide a reason fo
Page 35 and 36: • Akorn states the reason for the
Page 37 and 38: Reason for the Shortage • Teva st
Page 39 and 40: 15 gram Novaplus bulk vial, 1 count
Page 41 and 42: Milrinone Injection May 9, 2012 Pro
Page 43 and 44: • Ranbaxy has all discontinued me
Page 45 and 46: Doxorubicin Liposomal Injection May
Page 47 and 48: 1 mg/mL, 2 mL vial, 25 count (NDC 6
Page 49 and 50: • APP has leucovorin on shortage
Page 51 and 52: • West-Ward acquired Baxter’s o
Page 53 and 54: • Ethinyl estradiol/norethindrone
Page 55 and 56: Potassium chloride for injection, H
Page 57 and 58: Labetalol tablets, Sandoz 100 mg, 1
Page 59 and 60: the gray market. • Ferring has No
Page 61 and 62: Source website: www.ashp.org Loraze
Page 63 and 64: Fentanyl Injection 50 mcg/mL, Hospi
Page 65 and 66: Bupivacaine Injection May 17, 2012
Page 67 and 68: Article link: http://www.ashp.org/D
Page 69 and 70: Heparin Sodium Injection May 18, 20
Page 71 and 72: o Heparin sodium 10 unit/mL, 5 mL l
Page 73 and 74: Article link: http://www.ashp.org/D
Page 75 and 76: • Amphastar and Baxter have disco
Page 77 and 78: Fludarabine Injection May 21, 2012
Page 79 and 80:
TheraCys Intravesical Injection, Sa
Page 81 and 82:
Nystatin Oral Suspension May 22, 20
Page 83 and 84:
discontinued the 1 mg/mL 4 mL vials
Page 85 and 86:
10 gram vial (NDC 63323-0314-61) Va
Page 87 and 88:
10 mg/mL, 10 mL vial (NDC 63323-020
Page 89 and 90:
Papaverine injection Reason for the
Page 91 and 92:
• Mylan Institutional (formerly B
Page 93 and 94:
20 mg, 100 count (NDC 00781-1695-01
Page 95 and 96:
4 mL vial (NDC 00641-6008-10) 10 mL
Page 97 and 98:
20 mL vials (NDC 00069-1340-02) Ond
Page 99 and 100:
ecently changed old Baxter to new W
Page 101 and 102:
1 mg/mL, 2 mL vial, 25 count (new N
Page 103 and 104:
250 mg, 100 count unit dose (NDC 00
Page 105 and 106:
Granisetron Hydrochloride Injection
Page 107 and 108:
15 mg/mL, 10 mL vial (NDC 63323-048
Page 109 and 110:
Ampicillin Sulbactam May 30, 2012 P
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