Product Safety Recalls

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FINASTERIDE Recall D-0391-2023

Description: Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 71713-096-90 UPC 3 71713 09690 2

FINASTERIDE Recall D-0391-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0391-2023
Event ID91657
Original Package?1
Active SubstanceFINASTERIDE
Drug RouteORAL
DistributionUnited States including Puerto Rico and Canada
Quantity1,440,652 bottles
Recall ReasonCGMP Deviations: recalling drug products following an FDA inspection.
Drug ClassificationClass II
Drug Code Info20230308
Product NDC71713-096
Product NUIN0000175836 N0000000126
Drug UPC0371713096902 371713096902
Pharma Class (EPC)5-alpha Reductase Inhibitor [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 Identifier57GNO57U7G
Drug Application NumberANDA091643
Structured Product Labeling (SPL ID)ecdd4925-db44-f8de-e053-2995a90a83ed
Structured Product Labeling (SPL Set ID)df82de18-6113-4644-a54d-b57b646956c6
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