D-0391-2023 Class II Terminated
FDA drug recall D-0391-2023 was initiated by Accord Healthcare, Inc. on February 7, 2023 and is designated Class II. Reason for recall: CGMP Deviations: recalling drug products following an FDA inspection. The recall status is terminated (terminated April 22, 2024). Affected quantity: 1,440,652 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2023
- Initiation Date
- February 7, 2023
- Termination Date
- April 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,440,652 bottles
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
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Distribution Pattern
United States including Puerto Rico and Canada
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;