FDA-Drug2014-11-05Class II

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

Micro Labs Usa, Inc S
Hazard

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

Sold states
CT, FL, MD, MS, NY
Affected count
11,328 bottles
Manufactured in
104 Carnegie Ctr, Te 216, Princeton, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0046-2015

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