FDAFDA · Food and drugs·Recall number D-0390-2023
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
Published March 8, 2023 · Recall initiated: February 7, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: recalling drug products following an FDA inspection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FINASTERIDE
- Manufacturer
- Accord Healthcare, Inc.
- Distributor
- United States including Puerto Rico and Canada
- UPC
- 0316729089104
- Lot
- 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;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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