Status
Terminated
Drug Enforcement D-132-2013
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
Classification
Class II
Report Date
January 30, 2013
Termination Date
July 9, 2014
Product Information
- Product description
- 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.
- Product quantity
- 43,478 bottles
- Reason for recall
- Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled 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-132-2013
- Event ID
- 63967
- Recall initiation date
- November 30, 2012
- Center classification date
- January 18, 2013
- Code info
- Lot #: 69392A, 69393A, 69394A, 69395A, 69396A, 69397A , Exp 09/15; 69495A, 69496A, 69497A, 69498A, 69524A, 69525A, Exp 10/15
- More code info
- —