KENILWORTH,
N.J., Oct. 19, 2021 – Merck (NYSE: MRK), known as MSD outside the
United States and Canada, is voluntarily recalling one lot of CUBICIN®
(daptomycin for injection) 500mg for intravenous use, Lot 934778, Exp
June 2022. Because treatment with CUBICIN is likely to be initiated at
a hospital or other monitored healthcare setting, the recall is being
conducted to the user level, including hospital and administering
institutions. Approximately 22,000 vials are affected by this recall.
The recall has been initiated following receipt of a customer complaint
reporting that a piece of glass was found in a vial of CUBICIN after
reconstitution.
Intravenous
infusion of glass particulates has the potential to cause serious
health consequences if the particulate is small enough to be withdrawn
from the vial and infused into the patient. Local irritation or
swelling at the infusion site may occur in response to the presence of
foreign material. More serious potential outcomes include blockage and
clotting in blood vessels, which can be life-threatening if a critical
organ is affected. Other clinical consequences could include prolonged
hospitalization, particularly in those patients receiving an extended
treatment regimen for which multiple vials of CUBICIN are administered
over the course of treatment. The risk is reduced by the possibility of
detection, as the label contains a clear statement directing the
healthcare professional to visually inspect the product for particulate
matter prior to administration. To date, Merck has not received any
reports of adverse events related to this recall.
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