FDAHealthMarch 17, 2026
Chiesi USA, Inc. — CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 17, 2026
Nationwide within the United States
What's affected?
- 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
- CUROSURF
- Lot code
- 1213748
Additional details
Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7,235 vials.
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