FDAHealthJune 10, 2026
ACCORD BIOPHARMA INC — 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, N
⚠️ Lack of assurance of Sterility:
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 10, 2026
US Nationwide.
What's affected?
- 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.
- Brand
- IMULDOSA
- UPC
- 0369448017637
- Lot code
- 004L24A
Additional details
Lot # 004L24A, Exp Date: 02/19/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 326 vials.
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