HANOVER, NJ — More than five-million bottles of antihypertensives, statins, and other drugs made by Novartis may have been contaminated by a chemical used in their packaging, the company has confirmed. Novartis had issued a voluntary recall last summer for Exforge (amlodipine and valsartan) and Exforge HCT (with hydrochlorothiazide); news of the recall was posted publicly in an FDA enforcement report this week.
The recall also includes Diovan (valsartan), Tekturna (aliskiren) and Tekturna HCT; Lescol XL (fluvastatin); and Stalevo (carbidopa, levodopa, and entacapone) for Parkinson’s disease.
All of the drugs were given to physicians as free samples; a company spokesperson explained in an email to heartwire that routine testing by the company "found an out-of-specification result for a component of the inks used in the manufacturing of sleeves that are shrink-wrapped around the sample bottles. Over time, a trace amount of the component migrated through the sleeve and bottle, and affected some tablets." Additional testing concluded that there were no patient safety risks resulting from this packaging component issue.
A total of 127 drug lots were recalled in what the FDA classified as a class-2 recall (may cause temporary or medically reversible adverse health effects).
According to the Wall Street Journal , which reported the recall yesterday, Novartis is not sure how many samples may have actually made it into the hands of patients, saying it doesn’t track that information, but the company has sent letters to physicians who received the samples and worked with them to return the product. As well, use of the ink component for the sample sleeves, which are produced by a third-party manufacturer, has been discontinued, the company spokesperson confirmed.
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