Recalls / Class II
Class IID-0402-2026
Product
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
- Brand name
- Curosurf
- Generic name
- Poractant Alfa
- Active ingredient
- Poractant Alfa
- Route
- Endotracheal
- NDC
- 10122-510
- FDA application
- BLA020744
- Affected lot / code info
- Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Chiesi USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 175 Regency Woods Pl Ste 600, Cary, North Carolina 27518-6007
Distribution
- Quantity
- 7,235 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2026-03-17
- FDA classified
- 2026-03-20
- Posted by FDA
- 2026-04-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0402-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.