Exact FDA event identifier

Event 96232

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

Event summary

Timeline bucket: January 31, 2025
Product types: Drug
Classifications: Class II
Statuses: Completed
Recalling firm wording: Fagron Compounding Services

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

fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01

D-0225-2025

Recall number: D-0225-2025
Initiated: January 31, 2025
Classification: Class II
Status: Completed
Recalling firm: Fagron Compounding Services
Quantity: 1330 bags

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 # C274-000040409, Exp 03/22/2025

Distribution pattern

Distributed in PA