ASTRAZENECA PHARMACEUTICALS: Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distribute
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- ASTRAZENECA PHARMACEUTICALS
- Product
- 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
- Reason / hazard
- Lack of Assurance of Sterility:
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the U.S
- Recall initiated
- 2025-10-08
- Code info
- Lot YJ0152, Expiry: 01/31/2028.
- Product quantity
- 916 pre-filled syringes
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Gaithersburg
- State
- MD
- Country
- United States
- Event id
- 97760
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