Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bot...
FDA Recall #D-132-2013 — Class II — November 30, 2012
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.
Reason for Recall
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
Recalling Firm
West-ward Pharmaceutical Corp. — Eatontown, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
43,478 bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: 69392A, 69393A, 69394A, 69395A, 69396A, 69397A , Exp 09/15; 69495A, 69496A, 69497A, 69498A, 69524A, 69525A, Exp 10/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated