Recalls / Class II

Class IID-130-2013

Product

Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-10); Rx only, Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.

Affected lot / code info

Lot #: a) and b) 69545A, 69546A, 69546B, Exp 10/15; 69547A, Exp 11/15; 69995A, 69999A, 69999B, 70000A, 70001A, 70002A, 70002B, 70003A, 70004A, Exp 02/16; c) 69548A, 69549A, Exp 11/15; 69877A, Exp 02/16

Why it was recalled

Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.

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

32,550 bottles

Distribution pattern

Nationwide and Puerto Rico

Timeline

Recall initiated

2012-12-07

FDA classified

2013-01-18

Posted by FDA

2013-01-30

Terminated

2014-08-04

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-130-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.