Accord Healthcare, Inc.: Drug Recall

Recall #D-0391-2023 · 02/07/2023

Class II: Risk

Recall Details

Recall Number
D-0391-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Accord Healthcare, Inc.
Status
Terminated
Date Initiated
02/07/2023
Location
Durham, NC, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,440,652 bottles

Reason for Recall

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

Distribution Pattern

United States including Puerto Rico and Canada

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.