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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0393-2023
Event ID91657
BrandGLIMEPIRIDE
Generic NameGLIMEPIRIDE
ManufacturerGLIMEPIRIDE
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
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