Home › AMGEN INC. › Enbrel 25 mg/vial Multiple-use Vial

Enbrel 25 mg/vial Multiple-use Vial

AMGEN INC. · Model 642534 · UDI-DI 00358406425348

ONB FMF Prescription

510(k) clearances

4,967

Adverse events

Recalls

Facilities

Description

Carton contents (4 dose trays, 1 package insert with attached Medication Guide and mixing date stickers) are intended to be dispensed as a unit. Each dose tray contains one 25 mg vial of etanercept, one diluent syringe (1 mL Sterile Bacteriostatic Water for Injection, USP, containing 0.9% benzyl alcohol), one 27 gauge 1/2 inch needle, one vial adapter, and one plunger.

Recalls

Date	Firm	Reason
2026-05-12	ICU Medical, Inc.	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with
2026-05-12	ICU Medical, Inc.	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with
2026-03-24	ICU Medical, Inc.	Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy
2025-09-08	ICU Medical, Inc.	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08	ICU Medical, Inc.	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08	ICU Medical, Inc.	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08	ICU Medical, Inc.	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08	ICU Medical, Inc.	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08	ICU Medical, Inc.	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08	ICU Medical, Inc.	Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.