Fresenius Kabi issued a nationwide recall on Aug. 11 of Tyenne (tocilizumab-aazg) injection 400 mg/20 mL vials after confirming the presence of glass particles in affected lots. The contamination poses a serious risk to patients receiving the intravenous drug.
The FDA classified the recall as high-risk. Injection of glass particles can cause embolism, inflammation or organ damage, and the drug is frequently prescribed to immunocompromised patients who face elevated risk from adverse events.
Tocilizumab is used to treat rheumatoid arthritis, giant cell arteritis and cytokine release syndrome. The patients who rely on the drug are often among the most medically vulnerable, making contamination in this product category particularly dangerous.
The recall affects hospital pharmacies, infusion centers and specialty pharmacies nationwide. Healthcare providers who have received or possess the recalled product are advised to discontinue use, quarantine affected vials and contact Fresenius Kabi for replacement or return instructions.
Patients currently receiving tocilizumab therapy should consult their healthcare providers about alternative treatment options rather than abruptly discontinuing the medication, which could trigger disease flares. Other tocilizumab products not manufactured by Fresenius Kabi remain available.
Fresenius Kabi said it is investigating the root cause of the glass contamination and working with the FDA to ensure the issue is resolved before resuming distribution of the affected product line.