Reported Mar 8, 2023 · Terminated
Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; 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, 4 mg, Rx Only
- Packaged ina) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-count NDC 16729-003-16 UPC 3 16729 00316 2
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
- Lot codes and dates
- Batches
88 of 88 codes
a) P2001868Exp. Date 3/31/2023P2001869 Exp. Date 3/31/2023P2002810 Exp. Date 5/31/2023P2005473 Exp. Date 8/31/2023P2005552 Exp. Date 9/30/2023P2101986 Exp. Date 3/31/2024P2101989 Exp. Date 3/31/2024P2101988 Exp. Date 3/31/2024P2101991 Exp. Date 3/31/2024P2101992 Exp. Date 3/31/2024R2100736 Exp. Date 6/30/2024R2100737 Exp. Date 6/30/2024P2105281 Exp. Date 7/31/2024R2101441 Exp. Date 9/30/2024R2101454 Exp. Date 10/31/2024R2101455 Exp. Date 10/31/2024R2101468 Exp. Date 10/31/2024R2101469 Exp. Date 10/31/2024R2200096 Exp. Date 12/31/2024b)P2005550Exp. Date 9/30/2023P2005549 Exp. Date 9/30/2023P2005551 Exp. Date 9/30/2023P2005812 Exp. Date 10/31/2023P2005813 Exp. Date 10/31/2023P2005970 Exp. Date 10/31/2023P2005971 Exp. Date 10/31/2023P2005974 Exp. Date 10/31/2023P2005814 Exp. Date 10/31/2023P2005972 Exp. Date 10/31/2023P2005973 Exp. Date 10/31/2023P2005998 Exp. Date 10/31/2023P2005999 Exp. Date 10/31/2023P2006001 Exp. Date 10/31/2023P2005997 Exp. Date 10/31/2023P2006000 Exp. Date 10/31/2023P2100701 Exp. Date 1/31/2024P2100702 Exp. Date 1/31/2024P2100703 Exp. Date 1/31/2024P2100704 Exp. Date 1/31/2024P2102512 Exp. Date 3/31/2024P2101993 Exp. Date 3/31/2024P2101994 Exp. Date 3/31/2024P2102951 Exp. Date 4/30/2024P2102952 Exp. Date 4/30/2024P2102953 Exp. Date 4/30/2024P2102954 Exp. Date 4/30/2024R2100739 Exp. Date 6/30/2024R2100738 Exp. Date 6/30/2024R2100740 Exp. Date 6/30/2024P2104668 Exp. Date 6/30/2024P2104669 Exp. Date 6/30/2024P2104670 Exp. Date 6/30/2024P2105283 Exp. Date 7/31/2024P2105291 Exp. Date 7/31/2024P2105282 Exp. Date 7/31/2024P2105794 Exp. Date 7/31/2024P2105292 Exp. Date 7/31/2024P2105297 Exp. Date 7/31/2024
- Batches
- Amount recalled
- 1,158,839 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.
Want the full recall guide?
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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