Drug product
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01
D-0479-2024
Product summary
- Event
- Event 94481
- Status
- Terminated
- Classification
- Class II
- Quantity
- 251,504 syringes
- Official record key
drug-enforcement:D-0479-2024
Official wording
Reason: Lack of Assurance of Sterility: Complaints of syringe breakage
Code information: Lot # 8231500321, Exp 10/31 24; 8231500335, 8231500333, 8231500334, 8231500339, 8231500347, Exp 1/30/25
Distribution pattern: USA Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility