Drug recall D-0827-2026
Product
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.
Reason for recall
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Lots and codes
Lot: 16UI07, Exp 08/31/2028
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Quantity
- 4,643 20mL-vials
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 10, 2026
Related products
- Tyenne – drug information
- NDC 65219-594 Tyenne · Tocilizumab 400 mg/20mL · Fresenius Kabi USA, LLC
- NDC 65219-592 Tyenne · Tocilizumab 200 mg/10mL · Fresenius Kabi USA, LLC
- NDC 65219-590 Tyenne · Tocilizumab 80 mg/4mL · Fresenius Kabi USA, LLC