Exact FDA event identifier

Event 98593

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 17, 2026
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Chiesi USA, Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0402-2026

Recall number: D-0402-2026
Initiated: March 17, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Chiesi USA, Inc.
Quantity: 7,235 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.

Distribution pattern

Nationwide within the United States