Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Micro Labs Limited | Verna, India | Makes it | Problems found, fixed voluntarilyMay 30, 2025 · 6 inspections, 1 with FDA action |
Recalls
- Oct 9, 2014 · Class II · Micro Labs Usa, Inc S
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Lots: GLBG001 Exp.12/14, GLBG008 Exp. 06/15
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Glimepiride: every company that makes it
- Form
- tablet, oral
- Strength
- 1 mg
- Approval
- ANDA ANDA091220
- On the market since
- Jun 13, 2013
- Package NDCs
42571-100-0142571-100-05- Official label
- DailyMed (National Library of Medicine), updated May 12, 2025
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