FDA Drug Class II — Moderate

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.

Hazard

CGMP Deviations: Firm did not adequately investigate customer complaints.

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Products

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 Wat
Brand
Wockhardt Usa Inc.
UPC
Lot #: LN11320, Expiry: 7/31/2015; Lot #: LN11341, Expiry: 8/31/2015.

Units Affected

539 Drums

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