Fresenius Kabi recalls Tyenne (tocilizumab-aazg) 400 mg injection vials over glass particle contamination
Fresenius Kabi announced a recall of a specific lot of its Tyenne (tocilizumab-aazg) injection, 400 mg/20 mL vials, after detecting glass particles in the product.
The company said the contamination was discovered during an internal investigation and the recall is being carried out to the user level, meaning all distributed vials from that lot are being retrieved.
The presence of glass fragments can cause local irritation at the infusion site and, more seriously, may lead to vascular blockage, clot formation, pulmonary embolism, or permanent organ damage.
Tyenne is used to treat adult rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis in patients two years and older. The recall does not affect other batches of the drug.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Fresenius Kabi Issues Nationwide Recall of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL Vials Due to Presence of Glass Particles”
read at fda medwatch ↗
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