Drug product
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
D-0402-2026
Product summary
- Firm
- Chiesi USA, Inc.
- Event
- Event 98593
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,235 vials
- Official record key
drug-enforcement:D-0402-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility