FDA-Drug2023-05-31Class II
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
Amerisource Health Services LLC
Hazard
CGMP Deviations: recalling drug products following an FDA inspection.
Sold states
Nationwide USA
Affected count
63,335 bottles
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0757-2023Don't want to check this manually?
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