FDA recall D-0046-2015

Micro Labs Usa, Inc S · Class II · 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

Reason for recall

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

Distribution

CT, FL, MD, MS, NY

Key facts

Status: Terminated
Initiation date: 2014-10-09
Report date: 2014-11-05
Termination date: 2015-12-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

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