Tocilizumab-aazg

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. As of Aug. 12, Fresenius Kabi had not received any adverse event reports tied to the recall, a company spokesperson confirmed to Fierce. 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, which was 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. Editor's note: This story has been updated with a comment from a Fresenius Kabi spokesperson.

Fresenius Kabi is recalling one lot of Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL vials to the user level. An internal investigation at the firm found the product to contain glass particles. The administration of an injectable product containing glass particulates may cause local irritation, pain, or swelling at the infusion site, as well as inflammation of the veins. More seriously, glass particles can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death. Tyenne (tocilizumab-aazg) Injection is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs); adult patients with giant cell arteritis; patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis; patients 2 years of age and older with active systemic juvenile idiopathic arthritis; adults and pediatric patients 2 years of age and older with Chimeric Antigen Receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome; and certain hospitalised adult patients with COVID-19. Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL was distributed nationwide to wholesalers, distributors and direct customers. The company is notifying its distributors and customers by letter and is arranging for return of the recalled product. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.