Status
Terminated
Drug Enforcement D-130-2013
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.
Classification
Class II
Report Date
January 30, 2013
Termination Date
August 4, 2014
Product Information
- 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.
- Product quantity
- 32,550 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
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-130-2013
- Event ID
- 63871
- Recall initiation date
- December 7, 2012
- Center classification date
- January 18, 2013
- 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
- More code info
- —