FDAFDA · Food and drugs·Recall number D-0419-2023
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.
Published March 8, 2023 · Recall initiated: February 7, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: recalling drug products following an FDA inspection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PIRFENIDONE
- Manufacturer
- Accord Healthcare, Inc.
- Distributor
- United States including Puerto Rico and Canada
- UPC
- 316729467155
- Lot
- Batches: P2202518, P2202512, Exp. Date 4/30/2024, P2204588, P2204589, Exp. Date 7/31/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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