Home / Recalls / Wockhardt Usa Inc. / D-1276-2015

D-1276-2015 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
A) 216,329 Bottles and B) 18,514 Bottles.

Product Description

Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), 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 #: LM11093, Expiry: 6/30/2015; Lot #: LM11335, Expiry: 7/31/2015; Lot #: LM11336, Expiry: 7/31/2015; Lot #: LM11461, Expiry: 8/31/2015; Lot #: LM11462, Expiry: 8/31/2015; Lot #: LM11579, Expiry: 8/31/2015; Lot #: LM11778, Expiry: 9/30/2015; Lot #: LM11995, Expiry: 11/30/2015; Lot #: LN10029, Expiry: 11/30/2015; Lot #: LN10071, Expiry: 12/31/2015; Lot #: LN10349, Expiry: 1/31/2016; Lot #: LN10350, Expiry: 1/31/2016; Lot #: LN10505, Expiry: 2/29/2016; Lot #: LN10506, Expiry: 2/29/2016; Lot #: LN10814, Expiry: 3/31/2016; Lot #: LN10815, Expiry: 3/31/2016; Lot #: LN10977, Expiry: 4/30/2016; Lot #: LN11156, Expiry: 6/30/2016; Lot #: LN11260, Expiry: 7/31/2016. B) Lot #: LM10643, Expiry: 4/30/2015; Lot #: LM10846, Expiry: 5/31/2015; Lot #: LM11347, Expiry: 7/31/2015; Lot #: LM11492, Expiry: 8/31/2015; Lot #: LM11493, Expiry: 8/31/2015; Lot #: LM11577, Expiry: 8/31/2015; Lot #: LM11732, Expiry: 9/30/2015; Lot #: LM11994, Expiry: 11/30/2015; Lot #: LN10072, Expiry: 12/31/2015; Lot #: LN10073, Expiry: 12/31/2015; Lot #: LN10351, Expiry: 1/31/2016; Lot #: LN10561, Expiry: 2/29/2016; Lot #: LN10562, Expiry: 2/29/2016; Lot #: LN10816, Expiry: 3/31/2016; Lot #: LN10817, Expiry: 4/30/2016; Lot #: LN11162, Expiry: 6/30/2016; Lot #: LN11170, Expiry: 6/30/2016; Lot #: LN11171, Expiry: 6/30/2016.

Other recalls by Wockhardt Usa Inc.

  • D-0051-2018 Class III — Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured b (August 22, 2017)
  • D-1346-2015 Class II — Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wock (July 29, 2015)
  • D-1347-2015 Class II — Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Woc (July 29, 2015)
  • D-1246-2015 Class II — Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Cou (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)