Glimepiride Tablet
FDA Recall NDC 42571-101
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Glimepiride (NDC 42571-101). A significant event, classified as Class II, was initiated on Oct 09, 2014 by Micro Labs Limited. The reported reason for this action was: "Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Oct 09, 2014
Nov 05, 2014
11,328 bottles
Recall Profile & Regulatory Data
Event ID
69133
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Micro Labs Usa, Inc S
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
CT, FL, MD, MS, NY
Termination Date
Dec 29, 2015
Product Description
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
Affected Packages Involved in this Recall
42571-100-01Product
42571-100-05Product
42571-101-01Product
42571-101-05Product
42571-102-01Product
42571-102-05Product
42571-103-01Product
42571-103-05Product
42571-104-01Product
42571-104-05Product
42571-105-01Product
42571-105-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
