October 2014 FDA Recall Glimepiride by Micro Labs Usa, Inc S
D-0046-2015 - Failed Stability Specifications
This Class II drug recall was voluntarily initiated by Micro Labs Usa, Inc S on October 9, 2014 for the product Glimepiride. The FDA reported the reason for recall as failed stability specifications. The product was distributed in CT, FL, MD, MS, NY and the recall is currently terminated.
Recall Number: D-0046-2015
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
10-09-2014
11-05-2014
11,328 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Micro Labs Usa, Inc S
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
CT, FL, MD, MS, NY
12-29-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# GLBG001 Exp.12/14, GLBG008 Exp. 06/15
