Accord Healthcare, Inc. recalls Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-c
Recalled March 8, 2023 · FDA recall D-0393-2023 · Accord Healthcare
Hazard
CGMP Deviations: recalling drug products following an FDA inspection. · FDA Class II
Units
469,944 bottles
Sold at
United States including Puerto Rico and Canada
Description
CGMP Deviations: recalling drug products following an FDA inspection.
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
Manufacturer(s)
Accord Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →