Lisinopril Tablets recall: Impurity Out of Spec
Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.
Why was Lisinopril Tablets recalled?
Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) 68679A, 68679C, Exp 01/15; 64456A, Exp 04/15; 68980A, Exp 05/15; 69234A, 69235A, Exp 07/15; 69607A, Exp 11/15; 69609C, 69835A, Exp 01/16; b) 64455B, Exp 08/13; 64456C, Exp 04/14; 64457A, Exp 10/14, 68679B, 68680A, Exp 01/15; 68980B, Exp 05/15; 69607B, 69608A, Exp 11/15; 69609B, Exp 01/16; c) 64455A, 64455C, 64455D, Exp 08/13; 64456B, Exp 04/14; 64457B, Exp 10/14; 68680B, Exp 01/15; 68980C, 68981A, Exp 05/15; 69608B, Exp 11/15; 69609A, Exp 01/16; 70169A, Exp 05/16
- Product
- Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.
- Recalling firm
- West-Ward Pharmaceutical Corp.
- Quantity
- 51,704 bottles
- Distribution
- Nationwide
- Recall date
- August 14, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)