Home / Recalls / Wockhardt Usa Inc. / D-1346-2015

D-1346-2015 Class II Terminated

Recalled by Wockhardt Usa Inc. — Parsippany, NJ

Recall Details

Product Type: Drugs
Report Date: August 26, 2015
Initiation Date: July 29, 2015
Termination Date: April 12, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1704 bottles

Product Description

Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.

Reason for Recall

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Distribution Pattern

Nationwide

Code Information

Lot #: DM12700, Exp 09/15

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)
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D-1257-2015 Class II — Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 6467 (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-1246-2015 Class II — Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Cou (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-1252-2015 Class II — Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in (April 22, 2015)