Drug & medication recalls Moderate risk

Lisinopril Tablets USP recalled over manufacturing violations

Recall date
July 29, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Wockhardt Usa Inc. recalls Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distribut…
Recall number
D-1346-2015
FDA classification
Class II
Brand / firm
Wockhardt Usa Inc.
Sold / distributed
Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lisinopril 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.

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