United StatesTyenne (tocilizumab‑aazg) Injection, 400 mg/20 mL (20 mg/mL) in 20 mL vials (NDC 65219‑594‑20), Lot 16UI07, Exp 08/31/2028, manufactured by Fresenius Kabi USA, LLC and distributed nationwide in the U.S., is being recalled. The recall was issued because an internal investigation found the product may contain glass particles.
What's being recalled
Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.
Recalling firm: Fresenius Kabi USA, LLC, Lake Zurich, IL, United States.
How to identify it
Lot: 16UI07, Exp 08/31/2028
The hazard
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
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
Nationwide in the USA
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)