Glass was found in one vial of Cubicin, which treats patients with Staph infections of the skin and blood.
Merck is voluntarily recalling one lot of Cubicin (daptomycin for injection) 500 mg because a piece of glass was found in a vial. About 22,000 vials are affected by this recall.
The company warns that intravenous infusion of glass particulates has the potential to cause serious health consequences even if the glass is withdrawn from the vial. Serious potential outcomes include blockage and clotting in blood vessels, which can be life-threatening.
Cubicin is a lipopeptide antibacterial indicated for the treatment of complicated skin and skin structure infections in adult and pediatric patients, as well as Staphylococcus aureus bloodstream infections in adult patients and children.
Cubicin is packaged in single-dose, 10 mL glass vial containing 500 mg of daptomycin as a sterile, lyophilized cake, NDC 67919-011-01. There were 76,163 total vials manufactured in the affected lot; and of those vials, 21,603 have been distributed.
The affected lot includes the following: Bulk drug product and packaged lot 934778, expiration date June 2022. This product was distributed to wholesalers in the United States between June 1, 2021, and Sept. 9, 2021.