Recalls / Class II
Class IID-1355-2014
Product
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.
- Affected lot / code info
- Lot #: LN11423, Expiry: 8/15/15
Why it was recalled
Failed Dissolution Specifications: Failure of dissolution test observed at three month 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
- 8712 Bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-04-10
- FDA classified
- 2014-05-29
- Posted by FDA
- 2014-06-04
- Terminated
- 2015-08-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1355-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.