| Recall Number | D-0827-2026 |
|---|---|
| Recalling Firm | Fresenius Kabi USA, LLC |
| Classification | Class I |
| Voluntary / Mandated | Voluntary: Firm initiated |
| Distribution Pattern | Nationwide in the USA |
| Status | Ongoing |
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.
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Lot: 16UI07, Exp 08/31/2028