Glimepiride Tablet
FDA Recall NDC 16729-003
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Glimepiride (NDC 16729-003). A significant event, classified as Class II, was initiated on Feb 07, 2023 by Accord Healthcare Inc. The reported reason for this action was: "CGMP Deviations: recalling drug products following an FDA inspection."
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
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
469,944 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 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 for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Batch or Lot Expiration Information
Batch# 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. Date 2/28/2024, P2101781 Exp. Date 2/29/2024, P2102171 Exp. Date 2/29/2024, P2101844 Exp. Date 3/31/2024, P2101846 Exp. Date 3/31/2024, P2101845 Exp. Date 3/31/2024; b) P2006510 Exp. Date 11/30/2023, P2100975 Exp. Date 1/31/2024, P2100625 Exp. Date 1/31/2024, P2101778 Exp. Date 2/29/2024, P2101779 Exp. Date 2/29/2024, P2103021 Exp. Date 4/30/2024, P2103020 Exp. Date 4/30/2024, R2100657 Exp. Date 5/31/2024, R2100656 Exp. Date 5/31/2024, R2100658 Exp. Date 5/31/2024, P2104735 Exp. Date 7/31/2024, P2104739 Exp. Date 7/31/2024, P2104737 Exp. Date 7/31/2024, P2104738 Exp. Date 7/31/2024, P2106260 Exp. Date 9/30/2024, P2107384 Exp. Date 9/30/2024, R2200045 Exp. Date 12/31/2024, R2200046 Exp. Date 12/31/2024, R2200054 Exp. Date 12/31/2024, R2200055 Exp. Date 12/31/2024, R2200057 Exp. Date 12/31/2024, R2200058 Exp. Date 12/31/2024, R2200053 Exp. Date 12/31/2024, R2200059 Exp. Date 12/31/2024, R2200056 Exp. Date 12/31/2024, P2201929 Exp. Date 2/28/2025, R2200663 Exp. Date 4/30/2025, P2203518 Exp. Date 5/31/2025, R2200897 Exp. Date 6/30/2025, R2200898 Exp. Date 6/30/2025, R2200899 Exp. Date 6/30/2025, P2205528 Exp. Date 8/31/2025
Affected Packages Involved in this Recall
16729-001-01Product
16729-001-16Product
16729-001-17Product
16729-002-01Product
16729-002-16Product
16729-002-17Product
16729-003-01Product
16729-003-16Product
16729-003-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
992,622 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16 UPC 3 16729 00216 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Batch or Lot Expiration Information
Batch# 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. Date 3/31/2024, P2102068 Exp. Date 3/31/2024, P2102070 Exp. Date 3/31/2024, R2100659 Exp. Date 5/31/2024, R2100660 Exp. Date 5/31/2024, P2103898 Exp. Date 6/30/2024, P2106000 Exp. Date 7/31/2024, R2101442 Exp. Date 9/30/2024, P2201160 Exp. Date 1/31/2025, P2200695 Exp. Date 1/31/2025, P2200694 Exp. Date 1/31/2025; b) P2005530, Exp. Date 9/30/2023, P2005531 Exp. Date 9/30/2023, P2005532 Exp. Date 9/30/2023, P2005533 Exp. Date 9/30/2023, P2005846 Exp. Date 10/31/2023, P2006594 Exp. Date 11/30/2023, P2100602 Exp. Date 1/31/2024, P2100603 Exp. Date 1/31/2024, P2100604 Exp. Date 1/31/2024, P2100605 Exp. Date 1/31/2024, P2101571 Exp. Date 2/29/2024, P2101572 Exp. Date 2/29/2024, P2102046 Exp. Date 3/31/2024, P2102047 Exp. Date 3/31/2024, P2102049 Exp. Date 3/31/2024, P2102050 Exp. Date 3/31/2024, P2102051 Exp. Date 3/31/2024, P2102052 Exp. Date 3/31/2024, P2103017 Exp. Date 4/30/2024, P2103018 Exp. Date 4/30/2024, P2103900 Exp. Date 6/30/2024, P2104436 Exp. Date 6/30/2024, P2105399 Exp. Date 7/31/2024, P2105400 Exp. Date 7/31/2024, P2106257 Exp. Date 9/30/2024, P2106258 Exp. Date 9/30/2024, P2106259 Exp. Date 9/30/2024, R2101443 Exp. Date 9/30/2024, R2101445 Exp. Date 9/30/2024, R2101444 Exp. Date 9/30/2024, R2200082 Exp. Date 12/31/2024, R2200080 Exp. Date 12/31/2024, R2200079 Exp. Date 12/31/2024, R2200081 Exp. Date 12/31/2024, P2200691 Exp. Date 1/31/2025, P2200692 Exp. Date 1/31/2025, P2200693 Exp. Date 1/31/2025, P2201499 Exp. Date 2/28/2025, P2201498 Exp. Date 2/28/2025, R2200579 Exp. Date 4/30/2025, P2203881 Exp. Date 5/31/2025, P2203441 Exp. Date 5/31/2025, P2203442 Exp. Date 5/31/2025, R2200949 Exp. Date 6/30/2025, R2201094 Exp. Date 6/30/2025, R2201003 Exp. Date 7/31/2025
Affected Packages Involved in this Recall
16729-001-01Product
16729-001-16Product
16729-001-17Product
16729-002-01Product
16729-002-16Product
16729-002-17Product
16729-003-01Product
16729-003-16Product
16729-003-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
1,158,839 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 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 for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Batch or Lot Expiration Information
Batch# 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. Date 3/31/2024, R2100736 Exp. Date 6/30/2024, R2100737 Exp. Date 6/30/2024, P2105281 Exp. Date 7/31/2024, R2101441 Exp. Date 9/30/2024, R2101454 Exp. Date 10/31/2024, R2101455 Exp. Date 10/31/2024, R2101468 Exp. Date 10/31/2024, R2101469 Exp. Date 10/31/2024, R2200096 Exp. Date 12/31/2024; b)P2005550, Exp. Date 9/30/2023, P2005549 Exp. Date 9/30/2023, P2005551 Exp. Date 9/30/2023, P2005812 Exp. Date 10/31/2023, P2005813 Exp. Date 10/31/2023, P2005970 Exp. Date 10/31/2023, P2005971 Exp. Date 10/31/2023, P2005974 Exp. Date 10/31/2023, P2005814 Exp. Date 10/31/2023, P2005972 Exp. Date 10/31/2023, P2005973 Exp. Date 10/31/2023, P2005998 Exp. Date 10/31/2023, P2005999 Exp. Date 10/31/2023, P2006001 Exp. Date 10/31/2023, P2005997 Exp. Date 10/31/2023, P2006000 Exp. Date 10/31/2023, P2100701 Exp. Date 1/31/2024, P2100702 Exp. Date 1/31/2024, P2100703 Exp. Date 1/31/2024, P2100704 Exp. Date 1/31/2024, P2102512 Exp. Date 3/31/2024, P2101993 Exp. Date 3/31/2024, P2101994 Exp. Date 3/31/2024, P2102951 Exp. Date 4/30/2024, P2102952 Exp. Date 4/30/2024, P2102953 Exp. Date 4/30/2024, P2102954 Exp. Date 4/30/2024, R2100739 Exp. Date 6/30/2024, R2100738 Exp. Date 6/30/2024, R2100740 Exp. Date 6/30/2024, P2104668 Exp. Date 6/30/2024, P2104669 Exp. Date 6/30/2024, P2104670 Exp. Date 6/30/2024, P2105283 Exp. Date 7/31/2024, P2105291 Exp. Date 7/31/2024, P2105282 Exp. Date 7/31/2024, P2105794 Exp. Date 7/31/2024, P2105292 Exp. Date 7/31/2024, P2105297 Exp. Date 7/31/2024, P2105293 Exp. Date 7/31/2024, P2105295 Exp. Date 7/31/2024, P2105294 Exp. Date 7/31/2024, R2101408 Exp. Date 9/30/2024, R2101409 Exp. Date 9/30/2024, R2101410 Exp. Date 9/30/2024, R2101411 Exp. Date 9/30/2024, R2101412 Exp. Date 9/30/2024, R2101413 Exp. Date 9/30/2024, R2200089 Exp. Date 12/31/2024, R2200097 Exp. Date 12/31/2024, R2200100 Exp. Date 12/31/2024, R2200101 Exp. Date 12/31/2024, R2200088 Exp. Date 12/31/2024, P2200775 Exp. Date 1/31/2025, P2200776 Exp. Date 1/31/2025, P2201221 Exp. Date 1/31/2025, P2201347 Exp. Date 2/28/2025, P2201348 Exp. Date 2/28/2025, R2200481 Exp. Date 3/31/2025, R2200576 Exp. Date 4/30/2025, P2203378 Exp. Date 5/31/2025, P2203379 Exp. Date 5/31/2025, P2203377 Exp. Date 5/31/2025, R2200966 Exp. Date 6/30/2025, R2200964 Exp. Date 6/30/2025, R2200973 Exp. Date 6/30/2025, P2204893 Exp. Date 8/31/2025
Affected Packages Involved in this Recall
16729-001-01Product
16729-001-16Product
16729-001-17Product
16729-002-01Product
16729-002-16Product
16729-002-17Product
16729-003-01Product
16729-003-16Product
16729-003-17Product
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.
