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Recall Observatory FDA recall evidence

Drug 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

D-0531-2024

May 15, 2024

Class II

Product summary

Firm
Regeneron Pharmaceuticals Inc
Event
Event 94646
Status
Terminated
Classification
Class II
Quantity
405,725 Prefilled syringes
Official record key
drug-enforcement:D-0531-2024

Official wording

Reason: Lack of Assurance of Sterility: Complaints of syringe breakage

Code information: 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

Distribution pattern: USA nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility