FDA recall D-1271-2015

Wockhardt Usa Inc. · Class II · drug

Product

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0735-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Distribution

U.S. Nationwide including Puerto Rico.

Key facts

Status: Terminated
Initiation date: 2015-04-22
Report date: 2015-07-29
Termination date: 2018-05-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1271-2015