Merck Skin Recall Alert Staph Medication Due To Glass In Vial

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Merck issued a recall on October 19, 2021 of Cubicin 500 mg, lot 934778, due to the possible presence of glass particles.

United States FDA

Merck recalled a batch of its intravenous medicine Cubicin 500 mg which is used to treat infections after a customer complained that a piece of glass was found in one of the vials.

Cubicin, a lipopeptide antibacterial, is typically given in hospitals and healthcare facilities for the treatment of complicated infections of the skin and skin structures in adult and pediatric patients, according to the company. The injection is also used to treat bacterial infections of the bloodstream with Staphylococcus aureus in patients, including those with right-sided infective endocarditis – an infection in part of the heart.

What to look for

The affected drugs are from batch 934778, with an expiration date of June 2022. Approximately 22,000 vials are affected by this recall, which was initiated by Merck on October 19 and reported by the US Food & Drug Administration.

Cubicin is packaged in 10 ml single dose glass vials, of which a total of 76,163 vials were made in the affected lot. Of those vials, 21,603 were distributed nationwide to wholesalers between June 1 and September 9 in the United States.

What can happen?

Intravenous infusion of glass particles, or such foreign objects, can have serious health consequences, including irritation or swelling at the injection site, blockage and clotting in the blood vessels, which can cause life threatening if a critical organ is affected.

You might also be stuck in the hospital for a longer period of time, “particularly in patients receiving an extended treatment regimen where multiple vials of Cubicin are given during the course of treatment,” the FDA said.

To help minimize the risk of injecting foreign material into the body, the drug label urges healthcare professionals to visually inspect the product for particles before administering an injection.

As of the date of the recall notice, Merck has not received any adverse event reports related to this recall.

What you should do

Merck stated that it had informed its distributors and customers and had organized the return of the recalled bottles.

Customers with Cubicin vials from the recalled lot should call 877-830-9730 for instructions on returning the product.

If you have any questions about this recall, contact the Merck National Service Center at 800-672-6372 and select Prompt # 1 between 8 a.m. and 7 p.m. Eastern Time. If you have had any health problems after taking this medicine, tell your doctor or healthcare professional.

In a statement, Dr Richard Haupt, vice president of Vaccines and Infectious Diseases at Merck Research Labs, 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.

Miami Herald Real Time / Breaking News reporter Howard Cohen, winner of the 2017 Media Excellence Awards, has covered pop music, theater, health and fitness, obituaries, city government, and general missions. He began his career in the Features department of the Miami Herald in 1991.
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