Drug product
EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54
D-0531-2024
Product summary
- Event
- Event 94646
- Status
- Terminated
- Classification
- Class II
- Quantity
- 405,725 Prefilled syringes
- Official record key
drug-enforcement:D-0531-2024
Official wording
Reason: Lack of Assurance of Sterility: Complaints of syringe breakage
Code information: Lot # 8231500321, Exp. date Oct-24 8231500335, Exp. date Jan-25 8231500333, Exp. date Jan-25 8231500334, Exp. date Jan-25 8231500339, Exp. date Jan-25 8231500347, Exp. date Jan-25 8231500336, Exp. date Jan-25 8231500337, Exp. date Jan-25 8231500340, Exp. date Jan-25 8268700014 (sample lot) exp. date Jan-25
Distribution pattern: USA nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility