FDA recall D-0479-2024

Product

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

Reason for recall

Lack of Assurance of Sterility: Complaints of syringe breakage

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2024-04-23

Report date

2024-05-08

Termination date

2025-09-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

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