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

Recalled June 5, 2024 · FDA recall D-0531-2024 · Regeneron Pharmaceuticals

Hazard
Lack of Assurance of Sterility: Complaints of syringe breakage · FDA Class II
Units
405,725 Prefilled syringes
Sold at
USA nationwide.

Description

Lack of Assurance of Sterility: Complaints of syringe breakage

Product
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
Manufacturer(s)
Regeneron Pharmaceuticals Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

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