Class II · Moderate risk
Eylea
Lack of Assurance of Sterility: Complaints of syringe breakage
Libtayo (cemiplimab-rwlc)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was 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
Affected NDC
61755-0008-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Libtayo cemiplimab-rwlc NDC 61755-0008 |
CEMIPLIMAB 50 mg/mL | Injection Intravenous |
Regeneron Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Regeneron Pharmaceuticals Inc
- NDC code
- 61755-008-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0767-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Regeneron Pharmaceuticals Inc
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Class II · Moderate risk
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Lack of Assurance of Sterility: Complaints of syringe breakage
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