Recalls / Class II
Class IID-0191-2024
Product
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96
- Brand name
- Metoprolol Succinate
- Generic name
- Metoprolol Succinate
- Active ingredient
- Metoprolol Succinate
- Route
- Oral
- NDCs
- 45963-676, 45963-709, 45963-677, 45963-678
- FDA application
- ANDA204161
- Affected lot / code info
- Batch 2447J211
Why it was recalled
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling firm
- Firm
- CARDINAL HEALTHCARE
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7200 Cardinal Pl W, Dublin, Ohio 43017-1094
Distribution
- Quantity
- 1 unit
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2022-01-26
- FDA classified
- 2023-12-26
- Posted by FDA
- 2024-01-03
- Terminated
- 2024-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0191-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.