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FDAFDA · Food and drugs·Recall number D-1266-2015

Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09.

Published July 29, 2015 · Recall initiated: April 22, 2015

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

CGMP Deviations: Firm did not adequately investigate customer complaints.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Wockhardt Usa Inc.
Distributor
U.S. Nationwide including Puerto Rico.
Lot
Lot #: LN11320, Expiry: 7/31/2015; Lot #: LN11341, Expiry: 8/31/2015.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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