← FDA ENFORCEMENT
D-0479-2024Class II

Regeneron Pharmaceuticals Inc

Recalling firm
Regeneron Pharmaceuticals Inc
Product type
Drug
Status
Terminated
Report date
2024-05-08
Distribution
USA Nationwide
Firm state
NY
Product quantity
251,504 syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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

Code / lot info

Lot # 8231500321, Exp 10/31 24; 8231500335, 8231500333, 8231500334, 8231500339, 8231500347, Exp 1/30/25

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.