Exact FDA event identifier

Event 99216

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

Event summary

Timeline bucket: June 10, 2026
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: ACCORD BIOPHARMA 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

IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.

D-0653-2026

Recall number: D-0653-2026
Initiated: June 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: ACCORD BIOPHARMA INC
Quantity: 326 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 # 004L24A, Exp Date: 02/19/2027.

Distribution pattern

US Nationwide.