A nationwide recall is underway for one lot of Tyenne, an injectable medicine used to control inflammation in rheumatoid arthritis and several other conditions, after the manufacturer found glass particles inside the vials. Fresenius Kabi announced the action on August 10, and the U.S. Food and Drug Administration posted the company announcement the next day. The recall is at the user level, meaning hospitals, infusion centers, and clinics are being asked to pull the product and return it.
This is not a pill a patient can set aside. Tyenne is given intravenously, so anything in the vial goes directly into a vein. Regulators treat particulate contamination in an injectable differently from a labeling error.
