EYLEA recalled over sterility concerns

Recall date

May 15, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Regeneron Pharmaceuticals Inc recalls EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled…

Recall number

D-0531-2024

FDA classification

Class II

Brand / firm

Regeneron Pharmaceuticals Inc

Sold / distributed

USA nationwide.

Why it was recalled

Lack of Assurance of Sterility: Complaints of syringe breakage

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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