Product Safety Recalls

Product Recall Tracker

GLIMEPIRIDE Recall D-0393-2023

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

GLIMEPIRIDE Recall D-0393-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0393-2023
Event ID91657
Original Package?1
Active SubstanceGLIMEPIRIDE
Drug RouteORAL
DistributionUnited States including Puerto Rico and Canada
Quantity469,944 bottles
Recall ReasonCGMP Deviations: recalling drug products following an FDA inspection.
Drug ClassificationClass II
Drug Code Info20230308
Product NDC16729-001 16729-002 16729-003
Product NUIN0000175608 M0020795
Drug UPC316729001014 316729001168
Pharma Class (EPC)Sulfonylurea [EPC]
Pharma Class (CS)Sulfonylurea Compounds [CS]
Recall Initiation Date20230207
Report Date20230308
Classification Date20230302
Address1009 Slater Rd Ste 210B
Durham, NC 27703-8446
United States
Recalling FirmAccord Healthcare, Inc.
Initial Notification Letter
Unique Ingredient Identifier6KY687524K
Drug Application NumberANDA078181
Structured Product Labeling (SPL ID)8831579e-9150-f6f8-e053-2a95a90a3766
Structured Product Labeling (SPL Set ID)9b74fbac-9e04-4927-9981-1e3dace89c6d
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.