Home / Recalls / Wockhardt Usa Inc. / D-1300-2014

D-1300-2014 Class II Terminated

Recalled by Wockhardt Usa Inc. — Parsippany, NJ

FDA drug recall D-1300-2014 was initiated by Wockhardt Usa Inc. on Apr 1, 2014 and is designated Class II. Reason for recall: Failed Dissolution Specifications: failure of dissolution test observed at nine month time point. The recall status is terminated (terminated May 12, 2015). Affected quantity: 109,744 bottles.

Recall details

Product Type: Drugs
Report Date: May 14, 2014
Initiation Date: Apr 1, 2014
Termination Date: May 12, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 109,744 bottles

Product description

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.

Reason for recall

Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.

Distribution pattern

Nationwide

Code information

Lot #: LN10686, LN10687, LN10688, LN10707, LN10708, Exp 02/15

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1300-2014
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)