Safety alertSource: FDA Drug Enforcement Reports

Class II recall: Regeneron Pharmaceuticals Inc: Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Inf

Regeneron Pharmaceuticals has issued a Class II recall of Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), single-dose vials for intravenous infusion after dilution, NDC 61755-008-01. The recall notice cites a lack of assurance of sterility as the reason. The FDA classification indicates this is a Class II recall.

Most relevant for: patients with cutaneous squamous cell carcinoma receiving intravenous cemiplimab treatment

Read the original at FDA Drug Enforcement Reports

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