Recalls / Class II
Class IID-0451-2022
Product
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03
- 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# 21141983, 21141984 and 21141985, Exp 03/31/2023; Lots# 21142017, 21142018, 21142019, Exp 02/28/2023
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- American Health Packaging
- Manufacturer
- BluePoint Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 6,637 500-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-12-20
- FDA classified
- 2022-01-25
- Posted by FDA
- 2022-02-02
- Terminated
- 2023-03-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0451-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.