Curosurf intratracheal suspension recalled over lack of sterility assurance
Chiesi USA is recalling three lots of Curosurf (poractant alfa) Intratracheal Suspension for lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a sterile intratracheal product whose sterility cannot be assured, with no injuries stated.
Plain-English summary
Chiesi USA, Inc. is recalling CUROSURF (poractant alfa), 240 mg, intratracheal suspension, in 3 mL single-dose vials, prescription only, NDC 10122-510-03. About 7,235 vials were distributed nationwide within the United States. The FDA has classified this recall as Class II.
The recall was initiated for lack of assurance of sterility.
Affected product covers lot 1213748 (expiry 09/2026) and lots 1215076 and 1215077 (expiry 10/2026).
Clinicians and pharmacies can identify affected product by the NDC and lot numbers above, and may contact Chiesi USA, Inc. for further information.
The recalled product
- Product
- CUROSURF (PORACTANT ALFA)
- Brand
- CUROSURF
- Manufacturer
- Chiesi USA, Inc.
- Category
- Drug — Intratracheal suspension
- Affected units
- 7,235
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #: 1213748
- Exp. Date 09/2026
- 1215076
- 1215077
- Exp. Date 10/26.
Distribution
Distributed nationwide across the United States.
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