D-0402-2026 Class II Ongoing

Recalled by Chiesi USA, Inc. — Cary, NC

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.