Reported Mar 8, 2023 · Terminated
Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b)…
Accord Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446
Is this the product you have?
- Glimepiride Tablets USP, 1 mg, Rx Only
- Packaged ina) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-count bottle NDC 16729-001-16 UPC 3 16729 00116 8
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
- Lot codes and dates
- Batches
a) R2000166Exp. Date 4/30/2023P2003528 Exp. Date 6/30/2023P2005451 Exp. Date 8/31/2023P2005438 Exp. Date 8/31/2023P2005436 Exp. Date 8/31/2023P2005437 Exp. Date 8/31/2023P2005452 Exp. Date 8/31/2023P2006055 Exp. Date 9/30/2023P2101782 Exp. Date 2/28/2024P2101783 Exp. Date 2/28/2024P2101781 Exp. Date 2/29/2024P2102171 Exp. Date 2/29/2024P2101844 Exp. Date 3/31/2024P2101846 Exp. Date 3/31/2024P2101845 Exp. Date 3/31/2024b) P2006510 Exp. Date 11/30/2023P2100975 Exp. Date 1/31/2024P2100625 Exp. Date 1/31/2024P2101778 Exp. Date 2/29/2024P2101779 Exp. Date 2/29/2024P2103021 Exp. Date 4/30/2024P2103020 Exp. Date 4/30/2024R2100657 Exp. Date 5/31/2024R2100656 Exp. Date 5/31/2024R2100658 Exp. Date 5/31/2024P2104735 Exp. Date 7/31/2024P2104739 Exp. Date 7/31/2024P2104737 Exp. Date 7/31/2024P2104738 Exp. Date 7/31/2024P2106260 Exp. Date 9/30/2024P2107384 Exp. Date 9/30/2024R2200045 Exp. Date 12/31/2024R2200046 Exp. Date 12/31/2024R2200054 Exp. Date 12/31/2024R2200055 Exp. Date 12/31/2024R2200057 Exp. Date 12/31/2024R2200058 Exp. Date 12/31/2024R2200053 Exp. Date 12/31/2024R2200059 Exp. Date 12/31/2024R2200056 Exp. Date 12/31/2024P2201929 Exp. Date 2/28/2025R2200663 Exp. Date 4/30/2025P2203518 Exp. Date 5/31/2025R2200897 Exp. Date 6/30/2025R2200898 Exp. Date 6/30/2025R2200899 Exp. Date 6/30/2025P2205528 Exp. Date 8/31/2025
- Batches
- Amount recalled
- 469,944 bottles
This recall covers 67 products
The agency filed one notice per product. You are reading one of them; the other 66 are below.
54 more are in the archive.
Where it was sold
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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