Status
Terminated
Drug Enforcement D-853-2013
Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.
Classification
Class II
Report Date
August 14, 2013
Termination Date
June 3, 2014
Product Information
- Product description
- Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.
- Product quantity
- 51,704 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- West-ward Pharmaceutical Corp.
- Address
-
465 Industrial Way W, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-853-2013
- Event ID
- 65807
- Recall initiation date
- July 30, 2013
- Center classification date
- August 8, 2013
- Code info
- Lot #: a) 68679A, 68679C, Exp 01/15; 64456A, Exp 04/15; 68980A, Exp 05/15; 69234A, 69235A, Exp 07/15; 69607A, Exp 11/15; 69609C, 69835A, Exp 01/16; b) 64455B, Exp 08/13; 64456C, Exp 04/14; 64457A, Exp 10/14, 68679B, 68680A, Exp 01/15; 68980B, Exp 05/15; 69607B, 69608A, Exp 11/15; 69609B, Exp 01/16; c) 64455A, 64455C, 64455D, Exp 08/13; 64456B, Exp 04/14; 64457B, Exp 10/14; 68680B, Exp 01/15; 68980C, 68981A, Exp 05/15; 69608B, Exp 11/15; 69609A, Exp 01/16; 70169A, Exp 05/16
- More code info
- —