Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 ...
FDA Recall #D-0394-2023 — Class II — February 7, 2023
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
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Recalling Firm
Accord Healthcare, Inc. — Durham, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
992,622 bottles
Distribution
United States including Puerto Rico and Canada
Code Information
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,
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.