Drug Enforcement D-0479-2024

Lack of Assurance of Sterility: Complaints of syringe breakage

Status

Terminated

Classification

Class II

Report Date

May 8, 2024

Termination Date

September 25, 2025

Product Information

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
Product quantity
251,504 syringes
Reason for recall
Lack of Assurance of Sterility: Complaints of syringe breakage
Recall initiation reason
—
Initial firm notification
E-Mail
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-0479-2024
Event ID
94481
Recall initiation date
April 23, 2024
Center classification date
May 2, 2024
Code info
Lot # 8231500321, Exp 10/31 24; 8231500335, 8231500333, 8231500334, 8231500339, 8231500347, Exp 1/30/25
More code info
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