FDA-Drug2023-05-31Class II
Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, 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
129,849 bottles
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, 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-0759-2023Don't want to check this manually?
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