FDARecall 99603Medicines
What to do
The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.
Read the official notice on accessdata.fda.gov (opens in a new tab)
Hazard
Why it was recalled
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
FDA classification: Class I. FDA’s highest class: a reasonable probability that using the product will cause serious health consequences or death. Status: Ongoing.
Is it yours? Products and codes
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.
- Lot or code
- Lot: 16UI07, Exp 08/31/2028
- FDA recall number
- D-0827-2026
- Quantity
- 4,643 20mL-vials
Distribution (FDA): Nationwide in the USA
About this record
- Issued by
- U.S. Food and Drug Administration
- Firm
- Fresenius Kabi USA, LLC (other notices of this firm)
- Title
- Composed by Recalls Watch from fields of the record; FDA records have no title.