US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 17, 2023 (3 years ago)

Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection.

What was recalled

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

Recalling firm
Amerisource Health Services LLC
NDC code
68001-178-00
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0758-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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