Recalls / Class II
Class IID-0170-2023
Product
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-01.
- Brand name
- Metoprolol Succinate
- Generic name
- Metoprolol Succinate Er Tablets
- Active ingredient
- Metoprolol Succinate
- Route
- Oral
- NDCs
- 67877-590, 67877-591, 67877-592, 67877-593
- FDA application
- ANDA211143
- Affected lot / code info
- Lot #: 21142633, Exp 03/31/2023
Why it was recalled
Failed Dissolution Specification
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 6,336 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2023-01-05
- FDA classified
- 2023-01-20
- Posted by FDA
- 2023-02-01
- Terminated
- 2024-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0170-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.