Fresenius Kabi, an operating company of the Fresenius Group, has issued a nationwide recall of one lot of Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL vials in the US after an internal investigation found glass particles in the product.
According to the company, 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. In more serious cases, the glass particles could enter the bloodstream and potentially cause blood vessel blockage or clotting, which may cut off blood flow to vital organs. Such complications could lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death.
Tyenne (tocilizumab-aazg) injection is approved for several indications, including the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs); giant cell arteritis in adults; active polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in patients aged 2 years and older; severe or life-threatening cytokine release syndrome associated with chimeric antigen receptor (CAR) T-cell therapy in adults and children aged 2 years and older; and certain hospitalized adults with COVID-19.
Fresenius Kabi is notifying distributors and customers directly about the recall and is arranging for the return of affected products.
Healthcare facilities in the US that have the affected lot have been asked to immediately stop distributing, dispensing, or using the product and return all units to Fresenius Kabi.
Distributors have also been instructed to notify their customers who received or may have received the recalled product.
Patients are advised to contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.
Fresenius Kabi said the recall is being conducted with the knowledge of the US Food and Drug Administration.
The recalled product can be identified with the label below:
