CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial...

Published: April 1, 2026Recall ID: D-0402-2026Category: drugsCountry: US

Reason for Recall / Hazard

Lack of Assurance of Sterility

CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.

Field	Value
City	Cary
State	NC
Openfda › Nui › 1	N0000008294
Openfda › Nui › 2	N0000175778
Openfda › Nui › 3	N0000000079
Openfda › Unii	KE3U2023NP
Openfda › Route	ENDOTRACHEAL
Openfda › Rxcui › 1	259216
Openfda › Rxcui › 2	261329
Openfda › Spl id	6b713a41-2648-43f4-9a10-cc41a7e83ca0
Openfda › Brand name	CUROSURF
Openfda › Spl set id	99bef307-00bd-4379-9f45-ede1380e74d4
Openfda › Package ndc › 1	10122-510-03
Openfda › Package ndc › 2	10122-510-01
Openfda › Product ndc	10122-510
Openfda › Generic name	PORACTANT ALFA
Openfda › Product type	HUMAN PRESCRIPTION DRUG
Openfda › Pharm class pe	Alveolar Surface Tension Reduction [PE]
Openfda › Substance name	PORACTANT ALFA
Openfda › Pharm class epc	Surfactant [EPC]
Openfda › Pharm class moa	Surfactant Activity [MoA]
Openfda › Manufacturer name	Chiesi USA, Inc.
Openfda › Application number	BLA020744
Openfda › Is original packager	true
Event id	98593
Address 1	175 Regency Woods Pl Ste 600
Code info	Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
Postal code	27518-6007
Report date	20260401
Product type	Drugs
Product quantity	7,235 vials
Reason for recall	Lack of Assurance of Sterility
Voluntary mandated	Voluntary: Firm initiated
Recall initiation date	20260317
Initial firm notification	Letter
Center classification date	20260320