United StatesIMULDOSA (ustekinumab-srlf) Injection, 130 mg/26 mL (5 mg/mL) single‑dose vial, NDC 69448-019-26, Lot #004L24A, Exp 02/19/2027 is being recalled. It was recalled due to lack of assurance of sterility; 326 vials were distributed nationwide in the United States.
What's being recalled
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.
Recalling firm: Accord Biopharma Inc, Raleigh, NC, United States.
How to identify it
Lot # 004L24A, Exp Date: 02/19/2027.
The hazard
Lack of assurance of Sterility:
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)