EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactur
Summary
The FDA issued a Class II for EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose by Regeneron Pharmaceuticals Inc. Reason: Lack of Assurance of Sterility: Complaints of syringe breakage.
Details
Source
Drug Recall
External ID
D-0479-2024
Action Date
2024-05-08
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # 8231500321, Exp 10/31 24; 8231500335, 8231500333, 8231500334, 8231500339, 8231500347, Exp 1/30/25
Quantity Affected: 251,504 syringes
Reason for Recall
Lack of Assurance of Sterility: Complaints of syringe breakage
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-23
Company
Tarrytown, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 86 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Regeneron Pharmaceuticals Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Regeneron Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Regeneron Pharmaceuticals Inc have FDA actions?
Regeneron Pharmaceuticals Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0479-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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