Recalls / Class III
Class IIID-0304-2015
Product
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 .
- Affected lot / code info
- a) Lot # LN10392; Exp. 12/14 b) Lot # LN10360; Exp. 12/14
Why it was recalled
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing 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
- 1,118,400 extended release tablets
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-04-17
- FDA classified
- 2014-12-18
- Posted by FDA
- 2014-12-24
- Terminated
- 2015-08-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0304-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.