FDA-Drug2025-10-22Class II

Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30

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Hazard

Lack of Assurance of Sterility:

Sold states
Nationwide in the U.S
Affected count
916 pre-filled syringes
Manufactured in
950 Wind River Ln, Gaithersburg, MD, United States
Products
Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0028-2026

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