FDA recall D-1300-2014

Product

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.

Reason for recall

Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-04-01

Report date

2014-05-14

Termination date

2015-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1300-2014