Recall D-0653-2026

US Class II Ongoing · initiated 2026-06-10

Recalling firm

ACCORD BIOPHARMA INC, NC

Product

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.

Reason for recall

Lack of assurance of Sterility:

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