Last Updated on October 28, 2021 by The Health Master
A blood pressure medication is being recalled for possibly containing high levels of a cancer-causing impurity, according to a recall notice from the U.S. Food and Drug Administration (USFDA).
Lupin Pharmaceuticals Inc. is voluntarily recalling its Irbesartan and Hydrochlorothiazide tablets at the consumer level.
An analysis revealed that certain tested API batches were above the specification limit for the impurity, N-nitrosoirbesartan — a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
Out of an abundance of caution, Lupin is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the United States.
Irbesartan Tablets USP, 75mg, 150mg, and 300mg, are packaged in 30- and 90-count bottles and were distributed nationwide in the United States to wholesalers, drug chains, mail-order pharmacies and supermarkets.
Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg, and 300mg/12.5mg, are packaged in 30- and 90-count bottles and were distributed nationwide in the United States to wholesalers, drug chains, mail order pharmacie, and supermarkets.
Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification, and is arranging for the return of all the recalled product lots, according to the recall notice.
Patients taking the medications are advised to continue taking their medication and contact their pharmacist, physician or medical provider for advice regarding alternative treatment.
Consumers, wholesalers, distributors, and retailers with questions regarding this recall should call Inmar Rx Solutions Inc. at 855-769-3988 or 855-769-3989. For reimbursement, return the recalled lots to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle label.
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