Fresenius Kabi has pulled a single batch of its biosimilar Tyenne (tocilizumab-aazg) injection in 20 ml vials following the discovery of glass particles in the product.
The German-headquartered drugmaker confirmed the recall after an internal company investigation identified the contamination, prompting an immediate withdrawal from the US market.
Tyenne is a biosimilar referencing Roche’s IL-6 receptor antagonist Actemra, used to treat adults with severely active rheumatoid arthritis and giant cell arteritis.
The drug is also approved for use in paediatric patients with active polyarticular juvenile idiopathic arthritis and active systemic juvenile idiopathic arthritis, broadening the potential scope of any safety concern.
Fresenius has also indicated that Tyenne is cleared for use in adults and children with CAR T cell-induced severe or life-threatening cytokine release syndrome.
According to a recall notice posted on the FDA’s website, injecting medication contaminated with glass particles could cause irritation, pain, or swelling at the infusion site, as well as potential inflammation of the veins.
In more serious cases, glass particles introduced into the bloodstream can cause blockage and clotting of blood vessels, stopping blood flow to organs and potentially leading to life-threatening clots in the lungs.
At its most severe, an adverse event linked to such contamination could lead to permanent organ damage or death, Fresenius warned in the recall notice.
As of 12 August, a company spokesperson confirmed to Fierce that Fresenius Kabi had not received any adverse event reports connected to the affected batch.
The recalled lot was distributed across the United States and carried an expiration date of August 2028, meaning the product could still have been in active circulation.
Glass particle contamination has driven several notable product recalls across the pharmaceutical industry in recent years, affecting multiple manufacturers and drug types.
As recently as May, Sun Pharma pulled one lot of a chemotherapy product used to treat ovarian cancer, Kaposi sarcoma, and multiple myeloma after glass particles were discovered in some vials during production.
In 2024, Gilead Sciences recalled one batch of its COVID-19 treatment Veklury after detecting a glass particle in a vial, an issue that was initially flagged through a customer complaint.
Similar contamination-related recalls have also affected GSK and Pfizer in prior years, underscoring the persistent manufacturing challenge glass particle shedding poses across the industry.
This latest action from Fresenius Kabi follows a separate US recall announced last week, which centred on a mislabelling issue rather than particulate contamination.
In that notice, Fresenius Kabi said it was pulling one lot of morphine sulfate injection that was mislabelled and could contain a prefilled syringe of the more potent opioid dilaudid, raising serious medication safety concerns.