Drug recall D-0531-2024

Class II Terminated reported Jun 5, 2024

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

Reason for recall

Lack of Assurance of Sterility: Complaints of syringe breakage

Lots and codes

Lot # 8231500321, Exp. date Oct-24 8231500335, Exp. date Jan-25 8231500333, Exp. date Jan-25 8231500334, Exp. date Jan-25 8231500339, Exp. date Jan-25 8231500347, Exp. date Jan-25 8231500336, Exp. date Jan-25 8231500337, Exp. date Jan-25 8231500340, Exp. date Jan-25 8268700014 (sample lot) exp. date Jan-25

Recall details

Recalling firm
Regeneron Pharmaceuticals Inc, Tarrytown, NY
Quantity
405,725 Prefilled syringes
Distribution
USA nationwide.
Type
Voluntary: Firm initiated
Recall initiated
May 15, 2024
Terminated
September 25, 2025

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