Fresenius Kabi USA, LLC: Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, I
Read the official notice at FDA (press release) →
The text below is copied from the official FDA (press release) record. If anything differs, the official notice is correct.
- Company / brand
- Fresenius Kabi USA, LLC
- Product
- Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.
- Reason / hazard
- Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the USA
- Recall initiated
- 2026-08-10
- Product type
- Drugs,
- Code info
- Lot: 16UI07, Exp 08/31/2028
- Product quantity
- 4,643 20mL-vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lake Zurich
- State
- IL
- Country
- United States
- Event id
- 99603
- Enforcement url
- https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99603
- Enforcement id
- fda-drug-D-0827-2026
- Announced product
- Tyenne Injection 400 mg/20 mL vial
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