FDARecalled Sep 2, 2026 · #D-0827-2026
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.
Hazard
Class I — serious health risk
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Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. Classification: Class I Distribution: Nationwide in the USA
Product details
- 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.
- Type
- Drugs
- Manufacturer
- Fresenius Kabi USA, LLC
- Model numbers
- 16UI07
- UPCs
- —