FDA recall D-0757-2023

Product

Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; 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-0757-2023