FDA-Drug2014-08-27Class II

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

Wockhardt Usa Inc.
Hazard

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

Sold states
Nationwide
Affected count
11,661 HDPE bottles
Manufactured in
20 Waterview Blvd., Suite 3, Parsippany, NJ, United States
Products
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

Official notice

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

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief