One hundred and one production lots of the antibiotic Cubicin, the intravenously administered prescription used for the treatment of skin and bloodstream infections, was voluntarily recalled by Cubist Pharmaceuticals on August 6 due to the potential presence of glass particles in vials produced by a contract manufacturer.
When a glass particulate is present in an intravenous drug, patients are potentially at risk for the following:
- Life-threatening pulmonary emboli
- Mechanical block of the capillaries
- The formation of granulomas, a protective local inflammatory response to foreign material
According to the FDA, patients with a preexisting condition of trauma or another condition that affects the microvascular blood supply are at an increased safety risk.
What is Cubicin?
Cubicin is used to treat bacterial infections of the skin and underlying tissues. It is packaged in single-use vials and distributed nationwide. Common side effects include:
- Trouble sleeping
- Pain, redness, and swelling at the injection site
Cubist is notifying customers of the recall by letter and telephone, and anyone with an existing inventory of the product lots listed should determine whether they have product from the recalled lots and discontinue use and arrange for return and replacement of the affected lots. The company is expecting to recall about 50,000 vials of Cubicin that were manufactured between November 2011 and February 2014.
This is the third recall in 12 months for the Lexington, Massachusetts-based drug maker, although the previous two were on a much smaller scale, they also involved supplier issues. In each instance, the presence of glass particles triggered the recall. Like the previous two, this recall is precautionary, as no complaints of trace glass particles in vials or any adverse effects associated with the product have been reported to date.