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
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Classification
Class I
Status
Ongoing
Lot
Lot: 16UI07, Exp 08/31/2028
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Fresenius Kabi USA, LLC — Class I Recall | MedicineWatch US