Recalls / Class II
Class IID-1541-2014
Product
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
- Affected lot / code info
- Lot # a) LN11005, Exp 04/15; LN11006; Exp 04/15; b) LN10979; Exp. 04/15, LN10980; Exp. 04/15
Why it was recalled
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Recalling firm
- Firm
- Wockhardt Usa Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Waterview Blvd., Suite 3, Parsippany, New Jersey 07054
Distribution
- Quantity
- 11,661 HDPE bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-24
- FDA classified
- 2014-08-18
- Posted by FDA
- 2014-08-27
- Terminated
- 2015-11-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1541-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.