FDA recall D-0758-2023

Amerisource Health Services LLC · Class II · drug

Product

Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories

Reason for recall

CGMP Deviations: recalling drug products following an FDA inspection.

Distribution

Nationwide USA

Key facts

Status: Terminated
Initiation date: 2023-03-17
Report date: 2023-05-31
Termination date: 2024-09-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0758-2023