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  3. Recall Enforcement Event ID: 71946

Recall Enforment Report D-1347-2015

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Wockhardt Usa Inc., originally initiated on 07-29-2015 for the product Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06. The product was recalled due to cgmp deviations: an fda inspection identified inadequate investigations of past market complaints.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1347-201507-29-201508-26-2015Class II3378 bottlesLisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06.CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.Terminated
D-1346-201507-29-201508-26-2015Class II1704 bottlesLisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.Terminated