Recalls / Class II
Class IID-0129-2019
Product
Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
- Affected lot / code info
- Lot # 1220211M, Exp 02/2019
Why it was recalled
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 53,451 bottles
- Distribution pattern
- U.S.A. Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2018-10-19
- FDA classified
- 2018-11-01
- Posted by FDA
- 2018-10-31
- Terminated
- 2019-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0129-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.