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Legacy Pharmaceutical Packaging will recall one more lot of the heart and blood pressure drug losartan sent to Kroger Co. pharmacies because the drug contained a possible carcinogen.
Legacy packages bulk pharmaceuticals from drug manufacturers and provides the finished product to retailers such as Kroger Co.
The recalled drug was supplied by Torrent Pharmaceuticals, which last week recalled 104 lots of the blood pressure-lowering drug that had the nitrosamine impurity, N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA.
Legacy recalled one lot of 50 mg losartan potassium tables in 30-count bottles, on top of three lots of the same drug that it recalled in March. Legacy said it will notify distributors and customers in writing about the recall with instructions on how to return the product.
Cincinnati, Ohio-based Kroger Co. operates 2,270 pharmacies at grocery stores such as Kroger, Harris-Teeter, Fry’s, Smith’s and others. The retailer did not immediately respond to questions about the recall.
Drug companies have recalled hundreds of lots of the blood pressure and heart medications valsartan, losartan and irbesartan since July after testing revealed some versions had small amounts of suspected carcinogens. These medications are part of a large class called angiotensin II receptor blockers (ARBs), which lower blood pressure by widening or relaxing blood vessels.
Last month, the Food and Drug Administration said it will allow certain lots of the blood pressure drug losartan that contain NMBA to be shipped to pharmacies. The temporary measure is designed to avert a shortage of the critical medication – the nation’s ninth-most commonly prescribed drug.
The FDA said it will allow pharmacies to sell some products with tiny amounts of a nitrosamine impurity because staff scientists determined it will not increase a person’s cancer risk. But if consumers are unable to get the drug to treat conditions such as hypertension, heart failure or kidney disease, it could put them at risk.
The FDA’s temporary measure is meant to allow consumers access to the drug while manufacturers make batches of losartan that do not contain the impurity.