CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Chiesi USA, Inc.
- Reason for Recall:
- Lack of Assurance of Sterility
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Product Codes/Lot Numbers:
Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0402-2026
Related Recalls
Class I - Dangerous
Failed Dissolution Specifications: Out of specification result for dissolution.
Class I - Dangerous
Failed Dissolution Specifications: Out of specification result for dissolution.