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FDAFDA · Food and drugs·Recall number D-0304-2015

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 .

Published December 24, 2014 · Recall initiated: April 17, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Wockhardt Usa Inc.
Distributor
Nationwide.
Lot
a) Lot # LN10392; Exp. 12/14 b) Lot # LN10360; Exp. 12/14
Risk classification
Class III
Area (FDA)
drug
Country
United States

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