Status
Terminated
Drug Enforcement D-0395-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Classification
Class II
Report Date
March 8, 2023
Termination Date
April 22, 2024
Product Information
- 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
- Product quantity
- 1,158,839 bottles
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- United States including Puerto Rico and Canada
Location & Firm
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Address
-
1009 Slater Rd Ste 210B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0395-2023
- Event ID
- 91657
- Recall initiation date
- February 7, 2023
- Center classification date
- March 2, 2023
- Code info
- 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
- More code info
- —