D-0402-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 1, 2026
- Initiation Date
- March 17, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,235 vials
Product Description
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.