Recalls / Class II
Class IID-0269-2023
Product
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories
- Brand name
- Metoprolol Succinate
- Generic name
- Metoprolol Succinate Er Tablets
- Active ingredient
- Metoprolol Succinate
- Route
- Oral
- NDCs
- 68001-500, 68001-501, 68001-502, 68001-503
- FDA application
- ANDA211143
- Affected lot / code info
- Lots: (a) 21143211, EXP 03/31/2023; (b) 21143185, 21143193, EXP 02/28/2023
Why it was recalled
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- BluePoint Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- (a) 6670 100-count (b) 2666 500-count bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2023-01-11
- FDA classified
- 2023-02-15
- Posted by FDA
- 2023-02-22
- Terminated
- 2024-05-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0269-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.