- The U.S. Food & Drug Administration (FDA) is warning the public that some vials of Tyenne have been recalled.
- The affected vials are being recalled over concerns they may contain glass particles.
- Here’s how to tell if your medication is included in the recall.
If you have rheumatoid arthritis and take an injection medication to treat your symptoms, you may want to take another look at your medicine cabinet. Injection vials of the prescription arthritis medication Tyenne are being recalled nationwide, according to the U.S. Food & Drug Administration (FDA).
Tyenne is a common medication used for adults who have moderate to severe rheumatoid arthritis that hasn’t responded to other disease-modifying antirheumatic drugs (DMARDs). According to the FDA’s announcement, the drug is being recalled after an internal investigation at the manufacturer found glass particles in the affected vials.
The FDA warns that administering one of the recalled vials can cause “local irritation, pain, or swelling at the infusion site, as well as inflammation of the veins.” However, in more serious cases, the blockage in the veins caused by glass particles may “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.”
Here’s how to tell if your medication is impacted.
How to tell if your medication is included in the recall
The recall includes 400 mg/20 mL Tyenne injection vials, which were distributed nationwide to wholesalers, distributors, and direct customers. Check your medicine cabinet for the following information to see if your medication is included in the recall.
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Tyenne (tocilizumab-aazg) Injection
- Size: 400 mg / 20 mL (20mg/mL) vial
- NDC number: 65219-594-20
- Product code: 590120
- Lot number: 16UI07
- Expiration date: 08/2028
More information, including photos of the packaging, can be found in the FDA’s enforcement report.
What to do with a recalled product
As of right now, the FDA hasn’t reported any injuries or illnesses associated with the recall. However, they’re urging any consumers or healthcare facilities that have injection vials from the recalled lot to discontinue use immediately and return them to the manufacturer. You can also contact the company at 1-866-716-2459 with any questions about the recall.
If you’ve already used one of the recalled vials and have any health concerns, be sure to contact a doctor right away. You can also report adverse consequences to the company at 1-800-551-7176, productcomplaint.USA@fresenius-kabi.com, or adverse.events.USA@fresenius-kabi.com.
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