Recalls / Class II
Class IID-0046-2015
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
- Brand name
- Glimepiride
- Generic name
- Glimepiride
- Active ingredient
- Glimepiride
- Route
- Oral
- NDCs
- 42571-100, 42571-101, 42571-102, 42571-103, 42571-104, 42571-105
- FDA application
- ANDA091220
- Affected lot / code info
- GLBG001 Exp.12/14, GLBG008 Exp. 06/15
Why it was recalled
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Recalling firm
- Firm
- Micro Labs Usa, Inc S
- Manufacturer
- Micro Labs Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 104 Carnegie Ctr, Te 216, Princeton, New Jersey 08540-6232
Distribution
- Quantity
- 11,328 bottles
- Distribution pattern
- CT, FL, MD, MS, NY
Timeline
- Recall initiated
- 2014-10-09
- FDA classified
- 2014-10-27
- Posted by FDA
- 2014-11-05
- Terminated
- 2015-12-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0046-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.