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Merck Recalls About 22K Vials Of Antibiotic Injection Cubicin

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Merck & Co., Inc., known as MSD outside the U.S. and Canada, has recalled one lot of intravenous antibiotic Cubicin (daptomycin for injection) 500 mg for the potential presence of particulate matter identified as glass particles, the U.S. Food and Drug Administration or FDA said in a statement.

The potential presence of glass particles can cause serious health consequences if the particulate is small enough to be withdrawn from the vial and infused into the patient, causing local irritation or swelling at the infusion site.

The infusion of the recalled injection can also be more serious and life-threatening if a critical organ is affected, including blockage and clotting in blood vessels. This can also lead to prolonged hospitalization, particularly in those patients receiving an extended treatment regimen for which multiple vials of Cubicin are administered over the course of treatment.

As the treatment with Cubicin is likely to be initiated at a hospital or other monitored healthcare setting, the risk is reduced by the possibility of detection, as the label contains a clear statement directing visual inspection of the vial prior to administration.

However, Merck said it is yet to receive any reports of adverse events related to the use of the recalled product.

Cubicin is packaged in single-dose, 10 mL glass vial containing 500 mg of daptomycin as a sterile, lyophilized cake. The product was distributed to wholesalers between June 1, 2021, and September 9, 2021, in the U.S.

There were a total of 76,163 vials manufactured in the affected lot number 934778, with expiry date of June 2022. The recall involves only 21,603 vials as only these were distributed to date.

The recall was initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of Cubicin after reconstitution.

Cubicin is a lipopeptide antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) in adult and pediatric patients aged 1 to 17 years. It is also indicated for staphylococcus aureus bloodstream infections (bacteremia) in adult patients and in pediatric patients aged 1 to 17 years.

The Kenilworth, New Jersey-based company is arranging for return of all recalled product. All Merck direct consignees will be instructed to perform a sub-recall and notify all customers to whom they had distributed the lot.

The company has urged customers who have Cubicin vials from the lot that is being recalled to contact Sedgwick, who will provide all customers with prepaid shipping labels, packing slips and business reply cards.

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