D-1541-2014 Class II Terminated
FDA drug recall D-1541-2014 was initiated by Wockhardt Usa Inc. on Jul 24, 2014 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point. The recall status is terminated (terminated Nov 20, 2015). Affected quantity: 11,661 HDPE bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 27, 2014
- Initiation Date
- Jul 24, 2014
- Termination Date
- Nov 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,661 HDPE bottles
Product description
Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA
Reason for recall
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Distribution pattern
Nationwide
Code information
Lot # a) LN11005, Exp 04/15; LN11006; Exp 04/15; b) LN10979; Exp. 04/15, LN10980; Exp. 04/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1541-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026