Drug recall D-0653-2026
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:
Lots and codes
Lot # 004L24A, Exp Date: 02/19/2027.
Recall details
- Recalling firm
- ACCORD BIOPHARMA INC, Raleigh, NC
- Quantity
- 326 vials
- Distribution
- US Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 10, 2026
Related products
- Imuldosa – drug information
- NDC 69448-018 Imuldosa · Ustekinumab-srlf 90 mg/mL · Accord BioPharma Inc.
- NDC 69448-017 Imuldosa · Ustekinumab-srlf 45 mg/.5mL · Accord BioPharma Inc.
- NDC 69448-019 Imuldosa · Ustekinumab-srlf 130 mg/26mL · Accord BioPharma Inc.