Antibiotic Recalled for Glass Contaminant
An intravenous antibiotic has been recalled after a customer complaint alerted Cubist Pharmaceuticals, Inc. that a vial had tiny pieces of glass floating in the solution.
According to the United States Food and Drug Administration (FDA), one lot of Cubicin is being recalled after an internal investigation confirmed that one vial from the production lot had been contaminated by glass particulates -- potentially a consequence of unforeseen complications during the vial's production, according to Cubist.
According to the FDA, glass particles can be potentially life-threatening if they find their way into the blood-stream via intravenous administration. Past reports have indicated that thromboembolism -- a blocking of a blood vessel that can be caused by foreign particulates -- is likely to occur. The particulates could also earn a dangerous reaction from the immune system, promoting inflammation that may not die down for long amounts of time, as the immune system has no means to break down glass.
While no adverse events related to this discovery have been reported, Cubist voluntarily recalled all Cubicin produced alongside the contaminated vial in the interest of caution. The vials were distributed to medical facilities nationwide, and these faculties have been contacted by phone and letter to help speed up the recall process.
Strangely, this is not the only instance of foreign particulates contaminating inject able medical formula that has been reported this month. According to two other FDA releases, the drug company Hospira Inc. has recalled two anesthetic products after they were discovered to have been contaminated with metallic particulates -- which can cause not only thromboembolism, but allergic reactions in sensitive patients. No injuries resulting from these contaminations have been reported to the FDA.
The FDA announced the Cubicn recall on April 18.
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