Home / Recalls / Wockhardt Usa Inc. / D-1246-2015

D-1246-2015 Class II Terminated

Recalled by Wockhardt Usa Inc. — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
July 29, 2015
Initiation Date
April 22, 2015
Termination Date
May 9, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
53,894 Bottles

Product Description

Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Reason for Recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Distribution Pattern

U.S. Nationwide including Puerto Rico.

Code Information

A) Lot #: DM11488, Expiry: 4/30/2015; Lot #: DM12093, Expiry: 6/30/2015; Lot #: DM12540, Expiry: 7/31/2015. B) Lot #: DM11412, Expiry: 4/30/2015; Lot #: DM11642, Expiry: 5/31/2015; Lot #: DM11682, Expiry: 5/31/2015; Lot #: DM12094, Expiry: 6/30/2015; Lot #: DM12533, Expiry: 7/31/2015; Lot #: DM12609, Expiry: 7/31/2015; Lot #: DM12898, Expiry: 9/30/2015, Lot #: DM12899, Expiry: 9/30/2015; Lot #: DN10163, Expiry: 11/30/2015; Lot #: DN10273, Expiry: 11/30/2015; Lot #: DN10487, Expiry: 12/31/2015.

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  • D-1276-2015 Class II — Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64 (April 22, 2015)
  • D-1252-2015 Class II — Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in (April 22, 2015)
  • D-1272-2015 Class II — Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A (April 22, 2015)
  • D-1251-2015 Class II — Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only (April 22, 2015)
  • D-1254-2015 Class II — Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. M (April 22, 2015)
  • D-1264-2015 Class II — Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only (April 22, 2015)
  • D-1257-2015 Class II — Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 6467 (April 22, 2015)