PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 8, 2024 Initiated: April 23, 2024 #D-0479-2024

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

Reason for Recall

Lack of Assurance of Sterility: Complaints of syringe breakage

Details

Units Affected
251,504 syringes
Distribution
USA Nationwide
Location
Tarrytown, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Regeneron Pharmaceuticals Inc. Units affected: 251,504 syringes.
Why was this product recalled?
Lack of Assurance of Sterility: Complaints of syringe breakage
Which agency issued this recall?
This recall was issued by the FDA Drug on May 8, 2024. Severity: Moderate. Recall number: D-0479-2024.