Reported Nov 5, 2014 · Terminated

GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only,…

Micro Labs USA, Inc. S

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Micro Labs Usa, Inc S · 104 Carnegie Ctr · Princeton, NJ · 08540-6232

Is this the product you have?

    • GLIMEPIRIDE TABLETS
    • USP 2 mg
    • a)100 count bottle
    • (NDC 42571-101-01)
    • b) 500 count Bottle (NDC 42571-101-05)
    • Rx only
  • Manufactured byMicro Labs Limited, Goa-403 722, INDIA
  • Manufactured forMicro Labs USA, Inc., Princeton, NJ 08540
Lot codes and dates
    • GLBG001 Exp.12/14
    • GLBG008 Exp. 06/15
Amount recalled
11,328 bottles

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 29, 2015 · Data as of Sep 19, 5:02 PM UTC

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