Home / Recalls / Wockhardt Usa Inc. / D-1355-2014

D-1355-2014 Class II Terminated

Recalled by Wockhardt Usa Inc. — Parsippany, NJ

FDA drug recall D-1355-2014 was initiated by Wockhardt Usa Inc. on Apr 10, 2014 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Failure of dissolution test observed at three month time point. The recall status is terminated (terminated Aug 13, 2015). Affected quantity: 8712 Bottles.

Recall details

Product Type: Drugs
Report Date: Jun 4, 2014
Initiation Date: Apr 10, 2014
Termination Date: Aug 13, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8712 Bottles

Product description

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.

Reason for recall

Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.

Distribution pattern

Nationwide.

Code information

Lot #: LN11423, Expiry: 8/15/15

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1355-2014
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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