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FDAFDA · Food and drugs·Recall number D-1271-2015

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0735-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

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
A) Lot #: LN10967, Expiry: 4/30/2015; Lot #: LN10968, Expiry: 4/30/2015; Lot #: LN10969, Expiry: 4/30/2015; Lot #: LN11076, Expiry: 4/30/2015; Lot #: LN11077, Expiry: 4/30/2015; Lot #: LN11078, Expiry: 4/30/2015; Lot #: LN11126, Expiry: 5/31/2015; Lot #: LN11127, Expiry: 5/31/2015; Lot #: LN11326, Expiry: 6/30/2015; Lot #: LN11330, Expiry: 6/30/2015; Lot #: LN11331, Expiry: 6/30/2015; Lot #: LN11335, Expiry: 7/31/2015. B) Lot #: LN11093, Expiry: 4/30/2015; Lot #: LN11094, Expiry: 4/30/2015; Lot #: LN11095, Expiry: 4/30/2015; Lot #: LN11096, Expiry: 4/30/2015; Lot #: LN11097, Expiry: 4/30/2015; Lot #: LN11101, Expiry: 5/31/2015; Lot #: LN11102, Expiry: 5/31/2015; Lot #: LN11103, Expiry: 5/31/2015; Lot #: LN11107, Expiry: 5/31/2015; Lot #: LN11108, Expiry: 5/31/2015; Lot #: LN11131, Expiry: 5/31/2015; Lot #: LN11132, Expiry: 5/31/2015; Lot #: LN11133, Expiry: 5/31/2015; Lot #: LN11203, Expiry: 5/31/2015; Lot #: LN11204, Expiry: 5/31/2015; Lot #: LN11325, Expiry: 6/30/2015. C) Lot #: LN10988, Expiry: 4/30/2015. D) Lot #: LN11192, Expiry: 5/31/2015; Lot #: LN11197, Expiry: 5/31/2015; Lot #:LN11198, Expiry: 5/31/2015.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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