PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 8, 2023 Initiated: February 7, 2023 #D-0391-2023

Product 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

Reason for Recall

CGMP Deviations: recalling drug products following an FDA inspection.

Details

Recalling Firm
Accord Healthcare, Inc.
Units Affected
1,440,652 bottles
Distribution
United States including Puerto Rico and Canada
Location
Durham, NC

Frequently Asked Questions

What product was recalled?
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. Recalled by Accord Healthcare, Inc.. Units affected: 1,440,652 bottles.
Why was this product recalled?
CGMP Deviations: recalling drug products following an FDA inspection.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 8, 2023. Severity: Moderate. Recall number: D-0391-2023.