NDC 61919-250
Glimepiride 4 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Accord Healthcare Inc.'s NDC 16729-003.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | No problems foundJul 12, 2024 · 10 inspections |
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) R2000166, Exp. Date 4/30/2023, P2003528 Exp. Date 6/30/2023, P2005451 Exp. Date 8/31/2023, P2005438 Exp. Date 8/31/2023, P2005436 Exp. Date 8/31/2023, P2005437 Exp. Date 8/31/2023, P2005452 Exp. Date 8/31/2023, P2006055 Exp. Date 9/30/2023, P2101782 Exp. Date 2/28/2024, P2101783 Exp. Da… - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) R2000184, Exp. Date 4/30/2023, R2000183 Exp. Date 4/30/2023, P2002969 Exp. Date 5/31/2023, P2002970 Exp. Date 5/31/2023, P2005346 Exp. Date 8/31/2023, P2005847 Exp. Date 10/31/2023, P2006133 Exp. Date 10/31/2023, P2100682 Exp. Date 1/31/2024, P2102065 Exp. Date 3/31/2024, P2102067 Exp. … - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2001868, Exp. Date 3/31/2023, P2001869 Exp. Date 3/31/2023, P2002810 Exp. Date 5/31/2023, P2005473 Exp. Date 8/31/2023, P2005552 Exp. Date 9/30/2023, P2101986 Exp. Date 3/31/2024, P2101989 Exp. Date 3/31/2024, P2101988 Exp. Date 3/31/2024, P2101991 Exp. Date 3/31/2024, P2101992 Exp. Da…
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
- Strength
- 4 mg
- Approval
- ANDA ANDA078181
- On the market since
- Feb 4, 2016
- Package NDCs
61919-250-0461919-250-3061919-250-6061919-250-8261919-250-90- Official label
- DailyMed (National Library of Medicine), updated Jan 11, 2023
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?