FDA recall D-0451-2022

American Health Packaging · Class II · drug

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

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2021-12-20
Report date
2022-02-02
Termination date
2023-03-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0451-2022