Drug 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.
D-0419-2023
Product summary
- Event
- Event 91657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2614 cartons
- Official record key
drug-enforcement:D-0419-2023
Official wording
Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Code information: Batches: P2202518, P2202512, Exp. Date 4/30/2024, P2204588, P2204589, Exp. Date 7/31/2024
Distribution pattern: United States including Puerto Rico and Canada
Derived failure modes
-
Manufacturing or process control
CGMP Deviations