FDA-Drug2024-05-08Class II

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

Regeneron Pharmaceuticals Inc
Hazard

Lack of Assurance of Sterility: Complaints of syringe breakage

Sold states
USA Nationwide
Affected count
251,504 syringes
Manufactured in
777 Old Saw Mill River Rd, Tarrytown, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0479-2024

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