D-0420-2023 Class II Terminated
FDA drug recall D-0420-2023 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: 2641 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
- 2641 bottles
Product Description
Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-468-15, UPC 3 16729 46815 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: P2202519, P2202513 Exp. Date 4/30/2024