Drug recall D-0390-2023
Product
Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-count bottle NDC 16729-089-15 UPC 3 16729 08915 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: a) P2005979, Exp. Date 10/31/2023; P2100252, Exp. Date 12/31/2023; P2101710, Exp. Date 2/29/2024; b) P2100253, Exp. Date 12/31/2023; P2103035, Exp. Date 4/30/2024; P2103036, Exp. Date 4/30/2024;
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 325,356 bottles
- Distribution
- United States including Puerto Rico and Canada
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 7, 2023
- Terminated
- April 22, 2024
Related products
- Finasteride – drug information
- NDC 16729-089 Finasteride · Finasteride 1 mg/1 · Accord Healthcare, Inc.