Fresenius Kabi is yanking a batch of another product in the U.S., shortly after initiating a separate recall tied to mislabeled pain medicine.
Fresenius has issued a recall of its biosimilar Tyenne (tocilizumab-aazg) injection in 20 ml vials, after a company investigation found the product contained glass particles.
It likely goes without saying that injecting medication contaminated with glass particulates can have unintended consequences. Doing so could cause irritation, pain or swelling at the infusion site, as well as potential inflammation of the veins, Fresenius said in a recall notice posted on the FDA’s website.
In more serious cases, injected glass particles 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 worst, an adverse event from such a product could lead to permanent organ damage or death, the company warned.
Fresenius Kabi did not clarify in its Aug. 10 posting if it had received any adverse event reports related to the recall. The company did not immediately respond to Fierce’s question about whether it had received any such reports.
Tyenne is a biosimilar referencing Roche’s IL-6 receptor antagonist Actemra. It is used to treat certain adults with severely active rheumatoid arthritis, and those with giant cell arteritis. Fresenius’ drug is also cleared in pediatric populations for active polyarticular juvenile idiopathic arthritis and active systemic juvenile idiopathic arthritis, and in adults and kids with CAR T cell-induced severe or life-threatening cytokine release syndrome.
Fresenius’ recall covers a single lot of Tyenne, which was distributed across the U.S. and carried an expiration date of August 2028.
Glass particles shedding or otherwise turning up in vials of the drug have prompted multiple other product pulls in recent years.
As recently as May, generics powerhouse Sun Pharma yanked one lot of a chemotherapy in the U.S. after the discovery of glass particles in some vials of the product—used to treat ovarian cancer, Kaposi sarcoma and multiple myeloma—during production.
In 2024, Gilead Sciences recalled one batch of its COVID-19 med Veklury after detecting a glass particle in a vial, flagged by a customer complaint. And the issue also led to similar product pulls for GSK and Pfizer the year before that, to name just a few examples.
As for Fresenius, the German-headquartered drugmaker publicized a separate U.S. recall last week focused not on particulate contamination, but labeling gone wrong.
In that notice, Fresenius Kabi said it was pulling one lot of morphine sulfate injection that was mislabeled and could contain a prefilled syringe of the more potent opioid dilaudid.