The Recall Desk
HighFDA (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.

What this means for you

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

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

Distribution scope not specified by the agency.

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