D-0531-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 5, 2024
- Initiation Date
- May 15, 2024
- Termination Date
- September 25, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 405,725 Prefilled syringes
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: Complaints of syringe breakage
Distribution Pattern
USA nationwide.
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