FDA Drug Class II — Moderate

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.

Hazard

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

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Products

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 64
Brand
Wockhardt Usa Inc.
UPC
Lot #: DM13219, Exp 10/15; DM13428, Exp 11/15

Units Affected

3378 bottles

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