United StatesLibtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL) single‑dose vial, NDC 61755-008-01, Lot 8494000002, exp 7/31/28, manufactured and marketed by Regeneron Pharmaceuticals, is being recalled nationwide in the United States. The product was recalled due to lack of assurance of sterility.
What's being recalled
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01
Recalling firm: Regeneron Pharmaceuticals Inc, Tarrytown, NY, United States.
How to identify it
Lot: 8494000002, Exp 7/31/28
The hazard
Lack of Assurance of Sterility
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
USA Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)