The FDA has recalled Tyenne (tocilizumab-aazg) 400 mg/20 mL injection vials nationwide after glass particles were discovered inside some vials during a manufacturer investigation. Affected product identifiers include NDC 65219-594-20, product code 590120, lot 16UI07, exp. 08/2028. Consumers and healthcare facilities should stop using affected vials, return them to the manufacturer, and contact their healthcare provider if they have used a recalled vial. No injuries have been reported so far; additional details are available in the FDA enforcement report.
FDA Issues Nationwide Recall of Tyenne Injection Vials After Glass Particles Found
FDA Recalls Prescription Arthritis Meds NationwideRiska - Getty Images
If you or a loved one uses injectable medication for rheumatoid arthritis, check your supply now. The U.S. Food & Drug Administration (FDA) has announced a nationwide recall of certain Tyenne (tocilizumab-aazg) 400 mg/20 mL injection vials after the manufacturer’s internal investigation identified glass particles in affected vials.
Who Uses This Drug? Tyenne is prescribed for adults with moderate to severe rheumatoid arthritis when other disease-modifying antirheumatic drugs (DMARDs) have been ineffective.
Why the Recall Was Issued
The manufacturer found glass particles inside some vials during an internal review. The FDA warns that injecting contaminated vials may cause local irritation, pain, swelling, or vein inflammation at the infusion site. In rare but serious cases, glass particles could obstruct blood flow, potentially causing pulmonary embolism (a life-threatening blood clot in the lungs), permanent organ damage, or death.
Which Products Are Affected
Check your medicine cabinet for the exact product identifiers below. The recall covers 400 mg / 20 mL (20 mg/mL) Tyenne injection vials distributed nationwide to wholesalers, distributors, and direct customers.
- Product: Tyenne (tocilizumab-aazg) Injection
- Size: 400 mg / 20 mL (20 mg/mL) vial
- NDC Number: 65219-594-20
- Product Code: 590120
- Lot Number: 16UI07
- Expiration Date: 08/2028
For images of the packaging and additional details, see the FDA enforcement report available on the FDA website.
What To Do If You Have Affected Vials
Do not use any vials from the recalled lot. The FDA and manufacturer advise that consumers and healthcare facilities immediately discontinue use and return affected vials to the manufacturer. If you have questions about the recall, contact the company at 1-866-716-2459.
If you have already used a recalled vial and experience any symptoms or health concerns, contact your healthcare provider right away. You may report adverse events to the manufacturer at 1-800-551-7176 or by email to [email protected] or [email protected].
Current Status: As of the FDA announcement, no injuries or illnesses have been reported in connection with this recall.
Note: Keep this information handy and check medication vials carefully. If you administer injectable medications in a facility setting, notify your pharmacy and supply chain contacts immediately to verify stock and returns.
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