Exact FDA event identifier

Event 97653

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

Event summary

Timeline bucket: September 22, 2025
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: RC Outsourcing, LLC

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

Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.

D-0003-2026

Recall number: D-0003-2026
Initiated: September 22, 2025
Classification: Class II
Status: Terminated
Recalling firm: RC Outsourcing, LLC
Quantity: 2,669 syringes

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 # 20250708-768A26, BUD: Oct 06, 2025 20250715-944DF2 BUD: Oct 13, 2025 20250722-55C603 BUD: Oct 20, 2025 20250722-5DC113 BUD: Oct 20, 2025

Distribution pattern

Nationwide in the US