Product Safety Recalls

Product Recall Tracker

DOFETILIDE Recall D-0384-2023

Description: Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-491-12 UPC 3 16729 49112 9

DOFETILIDE Recall D-0384-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0384-2023
Event ID91657
Original Package?1
Active SubstanceDOFETILIDE
Drug RouteORAL
DistributionUnited States including Puerto Rico and Canada
Quantity113,571 bottles
Recall ReasonCGMP Deviations: recalling drug products following an FDA inspection.
Drug ClassificationClass II
Drug Code Info20230308
Product NDC16729-490 16729-491 16729-492
Product NUIN0000175426
Drug UPC316729491129
Pharma Class (EPC)Antiarrhythmic [EPC]
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 IdentifierR4Z9X1N2ND
Drug Application NumberANDA213338
Structured Product Labeling (SPL ID)d923a6e5-7b50-ee28-e053-2a95a90ad9a3
Structured Product Labeling (SPL Set ID)4c1a5a6d-bd69-473c-8caa-d0d242b7708d
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