Recalls / Class II
Class IID-0531-2024
Product
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
- Brand name
- Eylea
- Generic name
- Aflibercept
- Active ingredient
- Aflibercept
- Route
- Intravitreal
- NDC
- 61755-005
- FDA application
- BLA125387
- Affected lot / 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
Why it was recalled
Lack of Assurance of Sterility: Complaints of syringe breakage
Recalling firm
- Firm
- Regeneron Pharmaceuticals Inc
- Manufacturer
- Regeneron Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 777 Old Saw Mill River Rd, Tarrytown, New York 10591-6717
Distribution
- Quantity
- 405,725 Prefilled syringes
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2024-05-15
- FDA classified
- 2024-05-30
- Posted by FDA
- 2024-06-05
- Terminated
- 2025-09-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0531-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.