Drug product
Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
D-132-2013
Product summary
- Event
- Event 63967
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43,478 bottles
- Official record key
drug-enforcement:D-132-2013
Official wording
Reason: Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
Code information: Lot #: 69392A, 69393A, 69394A, 69395A, 69396A, 69397A , Exp 09/15; 69495A, 69496A, 69497A, 69498A, 69524A, 69525A, Exp 10/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance