Regeneron Pharmaceuticals Inc: Drug Recall

Recall #D-0479-2024 · 04/23/2024

Class II: Risk

Recall Details

Recall Number
D-0479-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Regeneron Pharmaceuticals Inc
Status
Terminated
Date Initiated
04/23/2024
Location
Tarrytown, NY, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
251,504 syringes

Reason for Recall

Lack of Assurance of Sterility: Complaints of syringe breakage

Product Description

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

Distribution Pattern

USA Nationwide

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.