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Regeneron Pharmaceuticals Inc: Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufacture

DrugsSource: FDA (drug) · Date: 2026-08-26

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Regeneron Pharmaceuticals Inc
Product
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
Reason / hazard
Lack of Assurance of Sterility
Classification
Class II
Status
Ongoing
Distribution / sold at
USA Nationwide
Recall initiated
2026-07-28
Code info
Lot: 8494000002, Exp 7/31/28
Product quantity
21,353 vials
Voluntary mandated
Voluntary: Firm initiated
City
Tarrytown
State
NY
Country
United States
Event id
99523
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