Drug 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
D-0046-2015
Product summary
- Event
- Event 69133
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,328 bottles
- Official record key
drug-enforcement:D-0046-2015
Official wording
Reason: Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Code information: GLBG001 Exp.12/14, GLBG008 Exp. 06/15
Distribution pattern: CT, FL, MD, MS, NY
Derived failure modes
-
Potency or specification failure
out of specification