Lupin Pharmaceuticals is voluntarily recalling two types of blood pressure medications after certain batches were shown to exceed the federal limit for a potentially cancer-causing impurity.
Per a notice from the U.S. Food and Drug Administration (FDA), the recall affects all of the company’s Irbesartan tablets (75 mg, 150 mg, and 300 mg), and Irbesartan and Hydrochlorothiazide tablets (150 mg/12.5 mg and 300 mg/12.5 mg)—both used to treat hypertension. The pills were packaged in 30- and 90-count bottles and sold nationwide at drugstores, supermarkets, and mail-in pharmacies.
Specific identifying information can be found in the notice here.
Lupin is stressing that there’s no reason to panic, and says the recall is being issued under an “abundance of caution.” The possible impurity—N-nitrosoirbesartan—was found in some batches during the manufacturing process, but not in any finished batches, according to the notice.
While retailers stocking the affected bottles are asked to ship them back to the manufacturer, patients taking the medication at home should continue taking the pills until they can contact their doctors to prescribe an alternative treatment. There have been no adverse reactions linked to the recalled batches, although you can submit reports on the FDA website.
N-nitrosoirbesartan has been classified as a “probable” carcinogen in laboratory tests by the FDA.
Recognize your brand’s excellence by applying to this year’s Brands That Matter Awards before the early-rate deadline, May 3.
