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
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Chiesi USA, Inc.
- Product
- CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
- Reason / hazard
- Lack of Assurance of Sterility
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the United States
- Recall initiated
- 2026-03-17
- Code info
- Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
- Product quantity
- 7,235 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Cary
- State
- NC
- Country
- United States
- Event id
- 98593
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