Chiesi CUROSURF (poractant alfa) recalled for lack of sterility assurance
Chiesi USA is recalling specific lots of CUROSURF, a medication given to premature infants to help them breathe. The company cannot confirm that all vials are sterile, which means they may be contaminated. No infections have been reported so far.
From the FDA notice · Read the official notice ↗ · All Chiesi recalls
What to do
- If you have CUROSURF with lot #1213748 (expires 09/2026) or lot #1215076 or #1215077 (expires 10/2026), do not use it.
- Contact your hospital or healthcare provider immediately if you have these lots.
- Ask your provider about safe alternative medications.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
- Sold in
- Nationwide
- Made for
- Infants (under 1 month)
Details
- Units affected
- 7,235 vials
- Illnesses reported
- None reported
- Manufactured in
- 175 Regency Woods Pl Ste 600, Cary, NC, United States
- Classification
- Class II
- Recall number
- D-0402-2026
In the FDA's words
- Description
- CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03. Lack of Assurance of Sterility Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26. Distribution: Nationwide within the United States Affected quantity: 7,235 vials
- Hazard
- Lack of Assurance of Sterility
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