Exact FDA event identifier

Event 96167

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

Event summary

Timeline bucket: January 17, 2025
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: McKesson

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

Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01

D-0213-2025

Recall number: D-0213-2025
Initiated: January 17, 2025
Classification: Class II
Status: Ongoing
Recalling firm: McKesson
Quantity: 192 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

Code information

Lot# 04647349, Exp Date 5/31/2029

Distribution pattern

Nationwide USA