Home / Recalls / Wockhardt Usa Inc. / D-1247-2015

D-1247-2015 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
37,791 Bottles

Product Description

Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01.

Reason for Recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Distribution Pattern

U.S. Nationwide including Puerto Rico.

Code Information

Lot #: DM11802, Expiry: 6/30/2015; Lot #: DM11803, Expiry: 6/30/2015; Lot #: DM12273, Expiry: 7/31/2015; Lot #: DM12274, Expiry: 7/31/2015.

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-1347-2015 Class II — Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Woc (July 29, 2015)
  • D-1346-2015 Class II — Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wock (July 29, 2015)
  • D-1272-2015 Class II — Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A (April 22, 2015)
  • D-1271-2015 Class II — Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A (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-1276-2015 Class II — Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64 (April 22, 2015)
  • D-1268-2015 Class II — Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count (April 22, 2015)
  • D-1254-2015 Class II — Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. M (April 22, 2015)