Recalls / Class II
Class IID-1300-2014
Product
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.
- Affected lot / code info
- Lot #: LN10686, LN10687, LN10688, LN10707, LN10708, Exp 02/15
Why it was recalled
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Recalling firm
- Firm
- Wockhardt Usa Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Waterview Blvd., Suite 3, N/A, Parsippany, New Jersey 07054
Distribution
- Quantity
- 109,744 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-04-01
- FDA classified
- 2014-05-02
- Posted by FDA
- 2014-05-14
- Terminated
- 2015-05-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1300-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.