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

FDA recall notice · announced November 5, 2014 · Micro Labs Usa, Inc S

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

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

Notes

Distribution: CT, FL, MD, MS, NY
Lot/code information: GLBG001 Exp.12/14, GLBG008 Exp. 06/15
Quantity: 11,328 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0046-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.