FDA-Drug2023-03-08Class II

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

Accord Healthcare, Inc.
Hazard

CGMP Deviations: recalling drug products following an FDA inspection.

Sold states
United States including Puerto Rico and Canada
Affected count
1,440,652 bottles
Manufactured in
1009 Slater Rd Ste 210B, N/A, Durham, NC, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0391-2023

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