Merck is recalling 1 lot of Cubicin® (daptomycin for injection) 500mg for intravenous use due to a customer complaint reporting that a piece of glass was found in a vial after reconstitution.
Cubicin is a lipopeptide antibacterial indicated for the treatment of complicated skin and skin structure infections in adult and pediatric patients aged 1 to 17 years. It is also approved for the treatment of Staphylococcus aureus bloodstream infections (bacteremia), in adult patients (including those with right-sided endocarditis) and in pediatric patients aged 1 to 17 years.
The recalled lot of Cubicin 500mg for intravenous use; NDC 67919-011-01; Lot 934778; Expiration date June 2022, was distributed to wholesalers between June 1, 2021 and September 9, 2021 in the United States. There are approximately 22,000 vials affected by this recall. Cubicin is supplied as a single-dose 10mL vial containing 500mg of daptomycin.
According to the Company, the intravenous infusion of glass particulates may lead to serious health consequences if the glass particulate is small enough to be withdrawn from the vial and infused into the patient. To date, the Company has not received reports of adverse events related to this recall.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
For more information regarding this recall contact the Merck National Service Center at (800) 672-6372.
Merck issues voluntary nationwide recall of Cubicin® (daptomycin for injection) 500 mg, lot 934778, due to presence of particulate matter identified as glass particles. News release. Merck. Accessed October 20, 2021. https://www.businesswire.com/news/home/20211019006241/en/Merck-Issues-Voluntary-Nationwide-Recall-of-CUBICIN%C2%AE-daptomycin-for-injection-500-mg-Lot-934778-Due-to-Presence-of-Particulate-Matter-Identified-as-Glass-Particles.