Home / Recalls / Wockhardt Usa Inc. / D-1266-2015

D-1266-2015 Class II Terminated

Recalled by Wockhardt Usa Inc. — Parsippany, NJ

FDA drug recall D-1266-2015 was initiated by Wockhardt Usa Inc. on Apr 22, 2015 and is designated Class II. Reason for recall: CGMP Deviations: Firm did not adequately investigate customer complaints. The recall status is terminated (terminated May 9, 2018). Affected quantity: 539 Drums.

Recall details

Product Type: Drugs
Report Date: Jul 29, 2015
Initiation Date: Apr 22, 2015
Termination Date: May 9, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 539 Drums

Product description

Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09.

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Distribution pattern

U.S. Nationwide including Puerto Rico.

Code information

Lot #: LN11320, Expiry: 7/31/2015; Lot #: LN11341, Expiry: 8/31/2015.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1266-2015
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Wockhardt Usa Inc.

D-0051-2018 Class III — Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured… (Aug 22, 2017)
D-1346-2015 Class II — Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by… (Jul 29, 2015)
D-1347-2015 Class II — Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by… (Jul 29, 2015)
D-1263-2015 Class II — Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC… (Apr 22, 2015)
D-1271-2015 Class II — Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in… (Apr 22, 2015)
D-1264-2015 Class II — Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx… (Apr 22, 2015)
D-1260-2015 Class II — Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC… (Apr 22, 2015)
D-1257-2015 Class II — Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC… (Apr 22, 2015)
D-1261-2015 Class II — Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC… (Apr 22, 2015)
D-1249-2015 Class II — Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only… (Apr 22, 2015)