FDA recall D-0269-2023

Amerisource Health Services LLC · Class II · drug

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

Reason for recall

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.

Distribution

Nationwide USA

Key facts

Status: Terminated
Initiation date: 2023-01-11
Report date: 2023-02-22
Termination date: 2024-05-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0269-2023