KENILWORTH, NJ (ABC4) – Merck is voluntarily recalling one lot of Cubicin®, also known as daptomycin. The product is being recalled following a customer complaint reporting a piece of glass was found in a vial of the medication after reconstitution.
According to Merck’s website, 76,163 total vials were manufactured in the affected lot. Of those vials, 21,603 have been distributed. The affected CUBICIN lot includes bulk drug products packaged from lot number 934778, with an expiration date of June 2022. This product was distributed to wholesalers between June 1, 2021, and Sept. 9, 2021, in the United States.
Cubicin is an antibiotic used in the treatment of complicated skin and skin structure infections in adult and pediatric patients (1-17 years of age). It also treats Staphylococcus aureus bloodstream infections (bacteremia) in adult patients.
“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of glass particulates has the potential to cause serious health consequences if the particulate is small enough to be withdrawn from the vial and infused into the patient,” the company said through a press release. They warn of local irritation and swelling at the point of infusion due to the presence of foreign matter.
“More serious potential outcomes include blockage and clotting in blood vessels, which can be life-threatening if a critical organ is affected,” officials say.
Other possible side-effects of the contaminated product include prolonged hospitalization, especially in patients receiving an extended treatment regimen for which they receive multiple vials of CUBICIN over the course of their treatment.
The risk is reduced by the possibility of detection. The label contains a clear statement directing healthcare professionals to visually inspect the product for particulate matter prior to administering. So far, Merck has not received any reports of adverse events related to this recall. Merck notified its distributors and customers and is arranging for the return of all recalled products by sending recall notices to all nine Merck direct consignees with a physical address.
“Our highest priorities are the health and safety of patients and the quality of our medicines and vaccines,” said Merck Vice President and Head of Vaccines & Infectious Diseases Richard M. Haupt. “We sincerely regret any inconvenience caused by this recall.”
Any adverse reactions or quality problems experienced from using Cubicin may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by mail, or by fax.
Online forms are available through the MedWatch website here. To request a reporting form via phone, call 1- 800-332-1088. Complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
To view the full FDA recall, click here.