Recalls / Class II

Class IID-853-2013

Product

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.

Affected lot / 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

Why it was recalled

Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.

Recalling firm

Firm

West-Ward Pharmaceutical Corp.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

465 Industrial Way W, N/A, Eatontown, New Jersey 07724-2209

Distribution

Quantity

51,704 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2013-07-30

FDA classified

2013-08-08

Posted by FDA

2013-08-14

Terminated

2014-06-03

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-853-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.