D-0479-2024 Class II Terminated

Recalled by Regeneron Pharmaceuticals Inc — Tarrytown, NY

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