Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 1...
FDA Recall #D-0390-2023 — Class II — February 7, 2023
Product Description
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.
Recalling Firm
Accord Healthcare, Inc. — Durham, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
325,356 bottles
Distribution
United States including Puerto Rico and Canada
Code Information
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;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated