FDAFDA · Food and drugs·Recall number D-1256-2015

Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, 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 #: DM12975, Expiry: 10/31/2015; Lot #: DM12976, Expiry: 10/31/2015; Lot #: DM12977, Expiry:10/31/2015; Lot #: DM12986, Expiry: 10/31/2015; Lot #: DM13259. Expiry: 10/31/2015; Lot #: DM13269, Expiry: 10/31/2015; Lot #: DM13270, Expiry: 11/30/2015; Lot #: DM13275, Expiry: 11/30/2015; Lot #: DM13339, Expiry: 11/30/2015; Lot #: DM13341, Expiry: 11/30/2015; Lot #: DM13369, Expiry: 11/30/2015; Lot #: DM13370, Expiry: 11/30/2015; Lot #: DN10088, Expiry: 12/31/2015; Lot #: DN10099, Expiry: 12/31/2015; Lot #: DN10939, Expiry: 3/31/2016; Lot #: DN10940, Expiry: 3/31/2016. B) Lot #: DM11422, Expiry: 5/31/2015; Lot #: DM11423, Expiry: 5/31/2015; Lot #: DM11424, Expiry: 5/31/2015; Lot #: DM11425, Expiry: 5/31/2015; Lot #: DM12634, Expiry: 9/30/2015; Lot #: DM12635; Expiry: 9/30/2015; Lot #: DM12660, Expiry: 9/30/2015; Lot #: DM12661, Expiry: 9/30/2015; Lot #: DM12662, Expiry: 9/30/2015; Lot #: DM12663, Expiry: 9/30/2015; Lot #: DM12673, Expiry: 9/30/2015; Lot #: DM12674, Expiry: 9/30/2015; Lot #: DM12684, Expiry: 9/30/2015; Lot #: DM12685, Expiry: 9/30/2015; Lot #: DM12985, Expiry: 10/31/2015; Lot #: DM13162, Expiry: 10/31/2015; Lot #: DM13163, Expiry: 10/31/2015; Lot #: DM13195, Expiry: 10/31/2015; Lot #: DM13196, Expiry: 10/31/2015; Lot #: DM13222, Expiry: 10/31/2015; Lot #: DM13223, Expiry: 10/31/2015; Lot #: DM13271, Expiry: 11/30/2015; Lot #: DM13272, Expiry: 11/30/2015; Lot #: DM13273, Expiry: 11/30/2015; Lot #: DM13274, Expiry: 11/30/2015; Lot #: DM13281, Expiry: 11/30/2015; Lot #: DM13282, Expiry: 11/30/2015; Lot #: DM13296, Expiry: 11/30/2015; Lot #: DM13297, Expiry: 11/30/2015: Lot #: DM13393, Expiry: 11/30/2015; Lot #: DM13394, Expiry: 11/30/2015; Lot #: DM13395, Expiry: 11/30/2015; Lot #: DM13403, Expiry: 11/30/2015; Lot #: DM13404, Expiry: 11/30/2015; Lot #: DM13415, Expiry: 11/30/2015; Lot #: DM13429, Expiry: 11/30/2015; Lot #: DN10077, Expiry: 12/31/2015; Lot #: DN10078, Expiry: 12/31/2015; Lot #: DN10079, Expiry: 12/31/2015; Lot #: DN10080, Expiry: 12/31/2015; Lot #: DN10081, Expiry: 12/31/2015; Lot #: DN10100, Expiry: 12/31/2015; Lot #: DN10104, Expiry: 12/31/2015; Lot #: DN10105, Expiry: 12/31/2015, Lot #: DN10336, Expiry: 12/31/2015; Lot #: DN10342, Expiry: 12/31/2015; Lot #: DN10343, Expiry: 12/31/2015; Lot #: DN10344, Expiry: 12/31/2015; Lot #: DN10355, Expiry: 12/31/2015; Lot #: DN10356, Expiry: 12/31/2015; Lot #: DN10811, Expiry: 2/29/2016; Lot #: DN10812, Expiry: 2/29/2016; Lot # DN10830, Expiry: 2/29/2016; Lot #: DN10874, Expiry: 2/29/2016; Lot #: DN10875, Expiry: 2/29/2016; Lot #: DN10876, Expiry: 2/29/2016; Lot #: DN10890, Expiry: 2/29/2016; Lot #: DN10891, Expiry: 2/29/2016; Lot #: DN10938, Expiry: 3/31/2016; Lot #: DN10956, Expiry: 3/31/2016.
Risk classification: Class II
Area (FDA): drug
Country: United States

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