Drug Enforcement D-0531-2024

Lack of Assurance of Sterility: Complaints of syringe breakage

Status

Terminated

Classification

Class II

Report Date

June 5, 2024

Termination Date

September 25, 2025

Product Information

Product description
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
Product quantity
405,725 Prefilled syringes
Reason for recall
Lack of Assurance of Sterility: Complaints of syringe breakage
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Regeneron Pharmaceuticals Inc
Address
777 Old Saw Mill River Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0531-2024
Event ID
94646
Recall initiation date
May 15, 2024
Center classification date
May 30, 2024
Code info
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
More code info
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