FDA recall D-1355-2014

Product

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

Nationwide.

Key facts

Status

Terminated

Initiation date

2014-04-10

Report date

2014-06-04

Termination date

2015-08-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1355-2014