FDA recall D-0171-2023

Product

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05.

Reason for recall

Failed Dissolution Specification

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2023-01-05

Report date

2023-02-01

Termination date

2024-08-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0171-2023