Due to a voluntary recall by the drug company Covidien, the Octreoscan Kit using Indium In-111 pentetreotide is not available at the present time in the United States or Canada. This means that carcinoid and neuroendocrine tumor patients cannot have an Octreoscan until the problem is solved.
The Octreoscan test is presently available in Europe, where the product is not experiencing the same issues as that of the Octreoscan manufactured and distributed in the United States. The reason the product has been recalled in the United States is because some complaints were received of poor labeling yield (also known as radiochemical purity). If the product were to be used it might show up in unintended locations within the body, possibly resulting in images that are not accurate.
The product was recalled in January. Because of the short half-life of Indium In-111 pentetreotide, 6 days, there are no lots currently available for use in an Octreoscan in North America. Covidien is working diligently to determine the cause of the problem and to return new lots of the kit to physicians and hospitals once they are manufactured to Covidien’s standards for the safe and effective use of the product.
As of February 4, 2010, a date has not yet been determined when the Octreoscan Kit will be returned to the market. It is suggested that patients check with their physicians about the Octreoscan test as the medical community will be informed by Covidien as soon as they have solved the problem and can return the kit to the market.