Drug Safety Alerts

Cubicin Voluntary Recall

11/10/2021

On November 10, 2021, the United States Food and Drug Administration (FDA) published a notice regarding a Class I recall of CUBICIN® (daptomycin for injection) 500mg for intravenous use, NDC # 67919-0011-01, manufactured by Merck. This recall was issued following receipt of a customer complaint reporting that a piece of glass was found in a vial of CUBICIN after reconstitution. This recall affects lot number 934778 exp. 06/30/2022. The affected lot was distributed between June 1, 2021 and September 9, 2021.

Please note: This recall was issued to the user level on October 20, 2021. The FDA classified this a Class I recall on November 10, 2021.

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of glass particulates has the potential to cause serious health consequences if the particulate is small enough to be withdrawn from the vial and infused into the patient.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. Merck has advised that as of the date of recall, it has not received any reports of adverse events related to this recall.

Consumers with questions regarding this recall can contact the Merck National Service Center at 1-800-672-6372, Monday to Friday 8:00 AM to 7:00 PM (ET) and select prompt #1, then please hold for a representative.

CVS Caremark Response: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about the recall of CUBICIN® (daptomycin for injection) 500 mg for intravenous use, please call Merck National Service Center at 1-800-672-6372, Monday to Friday 8:00 AM to 7:00 PM (ET) and select prompt #1, then please hold for a representative. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.