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

D-1245-2015 Class II Terminated

Recalled by Wockhardt Usa Inc. — Parsippany, NJ

FDA drug recall D-1245-2015 was initiated by Wockhardt Usa Inc. on Apr 22, 2015 and is designated Class II. Reason for recall: CGMP Deviations: Firm did not adequately investigate customer complaints. The recall status is terminated (terminated May 9, 2018). Affected quantity: 5,910 Bottles.

Recall details

Product Type: Drugs
Report Date: Jul 29, 2015
Initiation Date: Apr 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.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1245-2015
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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