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FDARecalled May 31, 2023 · #D-0759-2023

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-38...

Hazard

Class II — temporary health risk

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Description

CGMP Deviations: recalling drug products following an FDA inspection. Classification: Class II Distribution: Nationwide USA

Product details

Product
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
Type
Drugs
Manufacturer
Amerisource Health Services LLC
Model numbers
UPCs