US Drug Recall Register
Class II · Moderate risk Terminated Initiated Oct 9, 2014 (12 years ago)

GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count…

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

Why it was recalled

Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.

What was recalled

GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540

Recalling firm
Micro Labs Usa, Inc S
NDC code
42571-101-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0046-2015

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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