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Merck CUBICIN® 500mg - recalled due to Product contains glass, USA

2 years ago •source www.fda.gov

Recall notice

Merck CUBICIN® 500mg - recalled due to Product contains glass photo #1

United States

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of glass particulates has the potential to cause serious health consequences if the particulate is small enough to be withdrawn from the vial and infused into the patient.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. CUBICIN is a lipopeptide antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age), and Staphylococcus aureus bloodstream infections (bacteremia) in adult patients including those with right-sided infective endocarditis, and Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age).

CUBICIN is packaged in single-dose, 10 mL glass vial containing 500 mg of daptomycin as a sterile, lyophilized cake, NDC 67919-011-01. There were 76,163 total vials manufactured in the affected lot; and of those vials, 21,603 have been distributed. The affected CUBICIN lot includes the following: Bulk drug product and packaged lot 934778, expiration date June 2022. This product was distributed to wholesalers between June 1, 2021, and Sept. 9, 2021, in the U.S.

Merck is notifying its distributors and customers and is arranging for return of all recalled product by sending recall notices via UPS Next Day Air to all nine Merck direct consignees with a physical address.

Company name: Merck
Brand name: CUBICIN
Product recalled: Daptomycin for injection 500mg
Reason of the recall: Product contains particulate matter identified as glass
FDA Recall date: October 20, 2021

Check the full recall details on www.fda.gov

Source: FDA

#drugs #recall #blood #us #cake

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