Chiesi USA, Inc. is voluntarily recalling 7,235 vials of CUROSURF (poractant alfa), an intratracheal suspension used to treat respiratory distress syndrome in premature infants. The recall was initiated because the product lacks assurance of sterility, which is critical for an injectable or intratracheal medication. While no incidents or injuries have been reported to date, the company is recalling these specific lots from hospitals and specialty pharmacies nationwide.
A lack of sterility assurance means the medication may contain microorganisms that could lead to serious or life-threatening infections in vulnerable premature infants. Because this drug is administered directly into the lungs (intratracheal), any contamination poses a high risk of respiratory or systemic infection.
Recall #: D-0402-2026; 3L Single-dose-Vial; Rx only.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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