Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
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
Lot numbers, UPCs & expiration codes
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;
Where it was sold
United States including Puerto Rico and Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0391-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 7, 2023
- FDA report date
- Mar 8, 2023
- Quantity
- 1,440,652 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accord Healthcare, Inc.
Original FDA data
Every field from FDA enforcement report D-0391-2023, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 91657
- Address
- 1009 Slater Rd Ste 210B
- Code information
- 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;
- Postal code
- 27703-8446
- Report date
- Mar 8, 2023
- Product type
- Drugs
- Recall number
- D-0391-2023
- Classification
- Class II
- Recalling firm
- Accord Healthcare, Inc.
- Product quantity
- 1,440,652 bottles
- Termination date
- Apr 22, 2024
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- United States including Puerto Rico and Canada
- Recall initiation date
- Feb 7, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 2, 2023