D-0479-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2024
- Initiation Date
- April 23, 2024
- Termination Date
- September 25, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 251,504 syringes
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: Complaints of syringe breakage
Distribution Pattern
USA Nationwide
Code Information
Lot # 8231500321, Exp 10/31 24; 8231500335, 8231500333, 8231500334, 8231500339, 8231500347, Exp 1/30/25