D-0304-2015 Class III Terminated
FDA drug recall D-0304-2015 was initiated by Wockhardt Usa Inc. on Apr 17, 2014 and is designated Class III. Reason for recall: Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point. The recall status is terminated (terminated Aug 13, 2015). Affected quantity: 1,118,400 extended release tablets.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 24, 2014
- Initiation Date
- Apr 17, 2014
- Termination Date
- Aug 13, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,118,400 extended release tablets
Product description
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .
Reason for recall
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Distribution pattern
Nationwide.
Code information
a) Lot # LN10392; Exp. 12/14 b) Lot # LN10360; Exp. 12/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0304-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026