D-130-2013 Class II Terminated
FDA drug recall D-130-2013 was initiated by West-ward Pharmaceutical Corp. on December 7, 2012 and is designated Class II. Reason for recall: 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 tablet… The recall status is terminated (terminated August 4, 2014). Affected quantity: 32,550 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 30, 2013
- Initiation Date
- December 7, 2012
- Termination Date
- August 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,550 bottles
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
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