Class II

Drug Recall: 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 Ol

Regeneron Pharmaceuticals Inc · May 15, 2024

Reason for Recall

Lack of Assurance of Sterility: Complaints of syringe breakage

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

Distribution

USA nationwide.

States Affected

NATIONWIDE

Quantity Affected

405,725 Prefilled syringes

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0531-2024

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.