FDAClass IIMarch 8, 2023

Finasteride Tablets USP 1 mg recall: CGMP Deviations

Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas…

Why was Finasteride Tablets USP 1 mg recalled?

CGMP Deviations: recalling drug products following an FDA inspection.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batches: P2005583, P2005584, P2005585, P2005527, P2005528, P2005586, Exp. Date 9/30/2023; P2005980, Exp. Date 10/31/2023; P2100396, P2100264, P2100263, Exp. Date 12/31/2023; P2101583, P2101711, P2101708, P2101584, Exp. Date 2/29/2024; P2102852, P2102851, P2102853, P2102854, P2102855, Exp. Date 4/30/2024; P2103993, P2103998, P2103997, P2103999, P2104205, P2104206, P2105631, P2105632, P2105546, P2105547, P2105548 Exp. Date 8/31/2024;

Product
Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas…
Recalling firm
Accord Healthcare, Inc.
Quantity
1,440,652 bottles
Distribution
United States including Puerto Rico and Canada
Recall date
March 8, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls