Home / Recalls / Wockhardt Usa Inc. / D-1257-2015

D-1257-2015 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) 128,594 Bottles, B) 25,472 Bottles, and C) 62,124 Bottles.

Product Description

Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), 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 #: DM10991, Expiry: 4/30/2015; Lot #: DM11226, Expiry: 4/30/2015; Lot #: DM11665, Expiry: 6/30/2015; Lot #: DM11810, Expiry: 6/30/2015; Lot #: DM12702, Expiry: 9/30/2015; Lot #: DN10719, Expiry: 1/31/2016. B) Lot #: DM11651, Expiry: 6/30/2015; Lot #: DM11652, Expiry: 6/30/2015; Lot #: DM11664, Expiry: 6/30/2015; Lot #: DM12701, Expiry: 9/30/2015; Lot #: DN10139, Expiry: 12/31/2015. C) Lot #: DM11041, Expiry: 4/30/2015; Lot #: DM11267, Expiry: 4/30/2015; Lot #: DM11268, Expiry: 4/30/2015; Lot #: DM11279, Expiry: 5/31/2015; Lot #: DM11286, Expiry: 5/31/2015; Lot #: DM11292, Expiry: 5/31/2015; Lot #: DM11625, Expiry: 6/30/2015; Lot #: DM11626, Expiry: 6/30/2015; Lot #: DM11670, Expiry: 6/30/2015; Lot #: DM11772, Expiry: 6/30/2015; Lot #: DM11773, Expiry: 6/30/2015; Lot #: DM11809, Expiry: 6/30/2015; Lot #: DM12698, Expiry: 9/30/2015; Lot #: DN10110, Expiry: 11/30/2015; Lot #: DN10608, Expiry: 1/31/2016; Lot #: DN10642, Expiry: 1/31/2016; Lot #: DN10694, Expiry: 1/31/2016; Lot #: DN10744, Expiry: 1/31/2016; Lot #: DN10799, Expiry: 1/31/2016; Lot #: DN10839; Expiry: 2/29/2016.

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-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-1246-2015 Class II — Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Cou (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-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-1264-2015 Class II — Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only (April 22, 2015)