Regeneron Pharmaceuticals Inc: Drug Recall
Recall #D-0531-2024 · 05/15/2024
Class II: Risk
Recall Details
- Recall Number
- D-0531-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Regeneron Pharmaceuticals Inc
- Status
- Terminated
- Date Initiated
- 05/15/2024
- Location
- Tarrytown, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 405,725 Prefilled syringes
Reason for Recall
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
Distribution Pattern
USA nationwide.
Other Recalls by Regeneron Pharmaceuticals Inc
- Class II: Risk 04/23/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.