CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.

Recall Number: D-0402-2026

Firm: Chiesi USA, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20260401

Initiation Date: 20260317

Termination Date:

Reason for Recall

Lack of Assurance of Sterility

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.