FDA recall D-0304-2015

Product

Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .

Reason for recall

Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2014-04-17

Report date

2014-12-24

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-0304-2015