Class I Recall for Antibiotic Injection

A Class I recall has been issued for a single lot of Cubicin (daptomycin for injection) after a customer found glass particles found in a vial after reconstitution, according to the November 10, 2021, US Food and Drug Administration (FDA) Enforcement Report. A Class I designation, the FDA’s highest, communicates that use the affected product could cause serious adverse health consequences or death.

“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of glass particulates has the potential to cause serious health consequences if the particulate is small enough to be withdrawn from the vial and infused into the patient,” recalling firm Merck stated in an October 19, 2021, announcement. “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.”

The recall affects Cubicin, 500-mg vials (NDC 67919-011-01), from lot 934778 (Exp. 6/22). The vials were manufactured for Merck Sharp & Dohme Corp, a subsidiary of Merck & Co Inc, Whitehouse Station, NJ, by Baxter Pharmaceuticals, Bloomington, IN, and distributed  to wholesalers in the United States between June 1, 2021, and September 9, 2021.

“Because treatment with Cubicin is likely to be initiated at a hospital or other monitored healthcare setting, the recall is being conducted to the user level, including hospital and administering institutions,” Merck stated. “Approximately 22,000 vials are affected by this recall.”

Merck voluntarily initiated the recall October 19, 2021. The FDA issued its Class 1 designation on November 3, 2021.

Cubicin is a prescription antibiotic used to treat complicated skin and skin structure infections and Staphylococcus aureus bloodstream infections.