Drug 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.
D-0653-2026
Product summary
- Event
- Event 99216
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 326 vials
- Official record key
drug-enforcement:D-0653-2026
Official wording
Reason: Lack of assurance of Sterility:
Code information: Lot # 004L24A, Exp Date: 02/19/2027.
Distribution pattern: US Nationwide.
Derived failure modes
-
Sterility assurance
Lack of assurance of Sterility