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:
- Thromboembolism
- Life-threatening pulmonary emboli
- Phlebitis
- 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:
- Nausea
- Vomiting
- Constipation
- Diarrhea
- Headache
- Dizziness
- Trouble sleeping
- Anxiety
- 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.
Other Dangerous Drugs News
Research suggests Dupixent (dupilumab) may be linked to an increased risk of cutaneous T-cell lymphoma (CTCL). Learn what studies show, how CTCL may be misdiagnosed as eczema, and the legal options for patients diagnosed with lymphoma after taking Dupixent.
Childers, Schlueter & Smith has filed the first Dupixent lawsuit in Georgia, alleging a link between the eczema drug and cutaneous T-cell lymphoma (CTCL). The complaint highlights questions about risk disclosure.
A recent FDA-approved label change now warns of brain meningioma risks linked to Depo-Provera. This update explains what changed, why lawsuits are being filed, and what the warning may mean for women diagnosed with brain tumors.
While Suboxone helps fight opioid addiction, it’s now at the center of a growing legal battle over severe, preventable dental harm not disclosed to patients for years.
Women across the U.S. are filing lawsuits against Pfizer after a major study linked long-term use of Depo-Provera to a fivefold increase in the risk of developing brain tumors known as meningiomas.
Women diagnosed with meningiomas after using Depo-Provera may be eligible for financial compensation, as lawsuits claim Pfizer failed to warn about the potential risk of brain tumors.
