CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 275
Summary
The FDA issued a Class II for CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial by Chiesi USA, Inc.. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0402-2026
Action Date
2026-04-01
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
Quantity Affected: 7,235 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-17
Company
Cary, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Chiesi USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Chiesi USA, Inc. have FDA actions?
This is the only FDA action we have on record for Chiesi USA, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0402-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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