Agency classClass IIOur severity:High FDA (Drugs)·D-0391-2023·Announced 2023-03-08

Finasteride Tablets 1 mg Recalled for Manufacturing Quality Deviations

Accord Healthcare recalled 1.4 million bottles of Finasteride 1 mg tablets due to manufacturing quality deviations discovered during FDA inspection. No illnesses have been reported.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall without reported illnesses or injuries. The hazard is manufacturing process deviations (CGMP non-compliance) discovered during facility inspection, representing potential risk of harm but no confirmed specific contamination or adverse event. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the maximum score is 3.

Plain-English summary

Accord Healthcare, Inc. is recalling 1,440,652 bottles of Finasteride Tablets USP 1 mg in 90-count bottles under the Keeps brand (NDC 71713-096-90). The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection of the manufacturing facility.

The affected medication was distributed throughout the United States, including Puerto Rico and Canada. Multiple batch codes are involved, with expiration dates ranging from September 30, 2023, through August 31, 2024. For a complete list of affected batch codes, refer to FDA recall notice D-0391-2023 on the FDA website.

Consumers who have purchased this product should consult their healthcare provider for guidance. The FDA has not reported any illnesses or injuries associated with this recall.

The recalled product

Product: 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
Manufacturer: Accord Healthcare, Inc.
Category: Drug — Prescription Medication
Hazard: quality-control-failure
manufacturing-defect
Affected units: 1,440,652

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 67 products in this recall →

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