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FDARecalled Jul 8, 2026 · #D-0653-2026

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, Manufa...

Hazard

Class II — temporary health risk

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Description

Lack of assurance of Sterility: Classification: Class II Distribution: US Nationwide.

Product details

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.
Type
Drugs
Manufacturer
ACCORD BIOPHARMA INC
Model numbers
004L24A
UPCs