Recalls / Class II
Class IID-0393-2023
Product
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
- Brand name
- Glimepiride
- Generic name
- Glimepiride
- Active ingredient
- Glimepiride
- Route
- Oral
- NDCs
- 16729-001, 16729-002, 16729-003
- FDA application
- ANDA078181
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Manufacturer
- Accord Healthcare Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 469,944 bottles
- Distribution pattern
- United States including Puerto Rico and Canada
Timeline
- Recall initiated
- 2023-02-07
- FDA classified
- 2023-03-02
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0393-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.