Home / Recalls / Wockhardt Usa Inc. / D-1245-2015

D-1245-2015 Class II Terminated

Recalled by Wockhardt Usa Inc. — Parsippany, NJ

Recall Details

Product Type: Drugs
Report Date: July 29, 2015
Initiation Date: April 22, 2015
Termination Date: May 9, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,910 Bottles

Product Description

Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-271-01.

Reason for Recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Distribution Pattern

U.S. Nationwide including Puerto Rico.

Code Information

Lot #: DN10114, Expiry: 11/30/2015.

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