FDA recall D-0393-2022

Product

Metoprolol Succinate Extended-Release Tablets, USP, 25 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 67877-590-01.

Reason for recall

Failed Dissolution Specifications.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-01-12

Report date

2022-02-02

Termination date

2023-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0393-2022