Why it was recalled
Lack of Assurance of Sterility: Complaints of syringe breakage
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0531-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 15, 2024
- FDA report date
- Jun 5, 2024
- Quantity
- 405,725 Prefilled syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Regeneron Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0531-2024, exactly as published.
Show all FDA fields
- City
- Tarrytown
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 94646
- Address
- 777 Old Saw Mill River Rd
- Code information
- 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
- Postal code
- 10591-6717
- Report date
- Jun 5, 2024
- Product type
- Drugs
- Recall number
- D-0531-2024
- Classification
- Class II
- Recalling firm
- Regeneron Pharmaceuticals Inc
- Product quantity
- 405,725 Prefilled syringes
- Termination date
- Sep 25, 2025
- Reason for recall
- Lack of Assurance of Sterility: Complaints of syringe breakage
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA nationwide.
- Recall initiation date
- May 15, 2024
- Initial firm notification
- Letter
- Center classification date
- May 30, 2024