Drug recall D-0419-2023
Product
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Bottle NDC 16729-467-15, UPC 3 16729 46715 5; Carton NDC 16729-467-85, UPC 3 16729 46785 8.
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: P2202518, P2202512, Exp. Date 4/30/2024, P2204588, P2204589, Exp. Date 7/31/2024
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 2614 cartons
- Distribution
- United States including Puerto Rico and Canada
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 7, 2023
- Terminated
- April 22, 2024
Related products
- Pirfenidone – drug information
- NDC 16729-468 Pirfenidone · Pirfenidone 801 mg/1 · Accord Healthcare Inc.
- NDC 16729-467 Pirfenidone · Pirfenidone 267 mg/1 · Accord Healthcare Inc.