Merck has recalled one lot of its Cubicin 500mg intravenous drug that is used to treat infections after a customer complained a piece of glass was found in one of the vials.
Cubicin, a lipopeptide antibacterial, is usually administered at hospitals and healthcare settings for the treatment of complicated skin and skin structure infections in adult and pediatric patients, according to the company. The injection is also used to treat bacterial Staphylococcus aureus bloodstream infections in patients including those with right-sided infective endocarditis — an infection in a part of the heart.
What to look for
The affected medications are from Lot 934778, with an expiration date of June 2022. About 22,000 vials are affected by this recall, which was initiated by Merck on Oct. 19 and reported by the U.S. Food & Drug Administration.
Cubicin is packaged in single-dose, 10 milliliter glass vials of which 76,163 total vials were manufactured in the affected lot. Of those vials, 21,603 were distributed nationwide to wholesalers between June 1 and Sept. 9 in the U.S.
What can happen?
Intravenous infusion of glass particles, or such foreign material, can cause serious health consequences that can include irritation or swelling at the injection site, blockage and clotting in blood vessels — which can be life-threatening if a critical organ is affected.
You might also be stuck in the hospital for a longer time, “particularly in those patients receiving an extended treatment regimen for which multiple vials of Cubicin are administered over the course of treatment,” the FDA said.
To help minimize the risk of injecting foreign materials into the body, the drug’s label urges healthcare professionals to visually inspect the product for particles before administering a shot.
As of the recall notice, Merck has not received any reports of adverse events related to this recall.
What you should do
Merck said it had notified its distributors and customers and has arranged for the return of the recalled vials.
Customers that have Cubicin vials from the recalled lot should call 877-830-9730 for product return instructions.
If you have questions about this recall, contact Merck’s national service center at 800-672-6372 and select prompt #1 between 8 a.m.-7 p.m. eastern time. If you have had any health problems after taking this drug do make your physician or healthcare provider aware.
In a statement, Dr. Richard Haupt, vice president of Merck Research Labs’ Vaccines & Infectious Diseases department, said: “Our highest priorities are the health and safety of patients and the quality of our medicines and vaccines. We sincerely regret any inconvenience caused by this recall.”