FDA-Drug2024-06-05Class II
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
Regeneron Pharmaceuticals Inc
Hazard
Lack of Assurance of Sterility: Complaints of syringe breakage
Sold states
USA nationwide.
Affected count
405,725 Prefilled syringes
Manufactured in
777 Old Saw Mill River Rd, Tarrytown, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0531-2024Don't want to check this manually?
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