Drug 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
D-0028-2026
Product summary
- Event
- Event 97760
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 916 pre-filled syringes
- Official record key
drug-enforcement:D-0028-2026
Official wording
Reason: Lack of Assurance of Sterility:
Code information: Lot YJ0152, Expiry: 01/31/2028.
Distribution pattern: Nationwide in the U.S
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility