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Medicine / D-0827-2026

U.S. Food and Drug AdministrationD-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…

Class I Distributed nationwide or U.S.-wide Status: Ongoing

What was recalled

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.

Recalling firm

Fresenius Kabi USA, LLC

Reason for recall

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Where it went

Nationwide in the USA

Shown as U.S. Food and Drug Administration published it (shortened where marked …). Recall Shelf does not change recall facts and is not affiliated with the agency.