FDA recall D-1541-2014

Product

Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA

Reason for recall

Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-07-24

Report date

2014-08-27

Termination date

2015-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1541-2014