Fresenius Kabi Recalls Tyenne Injection Due to Glass Particles
Fresenius Kabi is recalling Tyenne (tocilizumab-aazg) injection vials because an internal investigation found the presence of glass particles.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classifies this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of glass particles in an intravenous injection presents a significant risk of injury.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 4,643 vials of Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL). The affected product is identified by Lot 16UI07 and has an expiration date of 08/31/2028. The product was distributed nationwide in the USA.
The recall was initiated after an internal investigation at the firm determined that the product contains glass particles. Tyenne is a prescription-only intravenous medication manufactured by Fresenius Kabi USA, LLC in Lake Zurich, Illinois.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the manufacturer for further instructions. The recall is classified as Class I by the FDA.
The recalled product
- Product
- TYENNE (TOCILIZUMAB-AAZG)
- Brand
- TYENNE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Prescription Injection
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 16UI07
- Exp 08/31/2028
Distribution
Distributed nationwide across the United States.
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