FDA-Drug2014-12-24Class III

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 .

Wockhardt Usa Inc.
Hazard

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

Sold states
Nationwide.
Affected count
1,118,400 extended release tablets
Manufactured in
20 Waterview Blvd., Suite 3, N/A, Parsippany, NJ, United States
Products
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 .

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0304-2015

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