Chiesi USA recalled 7,235 Curosurf vials distributed nationwide to hospitals and clinics. The recall cites a lack of assurance of sterility. Healthcare providers should stop using the product immediately and contact Chiesi USA for guidance.
Lack of Assurance of Sterility
Consumers and healthcare providers should stop using this product immediately. Contact Chiesi USA, Inc. or your healthcare provider for guidance. Notification method: Letter
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Curosurf is a neonatal surfactant used to treat respiratory distress in preterm infants. It is delivered intratracheally in a hospital setting.
Lack of sterility could introduce microbial contamination, potentially causing infection in vulnerable neonates.
This recall is not indicated as part of a broader industry pattern at this time.
Hospitals must halt use of affected vials and coordinate with distributors for replacement; potential patient risk if contaminated product is administered.
NDC and lot numbers are printed on vial labels and packaging.
Replacements or credits are typically coordinated within hospital supply chains over several weeks; patient care adjustments may occur during this时间.
Keep a copy of the recall notice, purchase records, lot numbers, and all correspondences with the supplier.
Product: Curosurf (poractant alfa) Intratracheal Suspension, 240 mg, 3L Single-Dose Vial, Rx only. NDC: 10122-510-03. Distributed nationwide to healthcare facilities. Quantity recalled: 7,235 vials. Lot numbers: 1213748, 1215076, 1215077. Expiration dates observed: 09/2026 and 10/2026. Sold by: Nationwide healthcare distribution. Manufacturer: Chiesi USA, Inc., Cary, NC.
No injuries or incidents have been reported.
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