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Fresenius Kabi USA, LLC: Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, I

DrugsSource: FDA (drug) · Date: 2026-09-02

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Fresenius Kabi USA, LLC
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 / hazard
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Classification
Class I
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-08-10
Code info
Lot: 16UI07, Exp 08/31/2028
Product quantity
4,643 20mL-vials
Voluntary mandated
Voluntary: Firm initiated
City
Lake Zurich
State
IL
Country
United States
Event id
99603
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