FDA nationwide recall has been issued for a rheumatoid‑arthritis medication after glass particles were discovered in certain vials, according to the U.S. Food and Drug Administration.
Fresenius Kabi is recalling one lot of Tyenne (tocilizumab‑aazg) 400 mg/20 mL injection vials. The affected lot is 16UI07, with an expiration date of August 2028. The product was distributed to wholesalers and direct customers across the United States.
The FDA warns that injecting medication containing glass particles can lead to vein irritation, blockage of blood vessels, pulmonary embolism, or other serious complications.
Patients and providers should stop using the recalled lot immediately. Anyone who has already used Tyenne from the affected lot and is experiencing symptoms should contact a medical professional.
Product questions can be directed to Fresenius Kabi at 1.866.716.2459
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