The FDA has announced that Sandoz is voluntarily recalling one lot of losartan potassium and hydrochlorothiazide 100mg/25mg tablets after tests showed it tested positive for a potential cancer-causing chemical, N-Nitrosodiethylamine or NDEA. The lot number is JB8912.
The ingredient was made by Zehjiang Huahai Pharmaceutical Company Ltd. Which the FDA placed on an import alert at the end of September. Meaning none of their products are permitted to enter the United States. There have been many recalls pertaining to blood pressure medication that contain valsartan and irbesartan which also tested positive for NDEA.
Not all medications containing valsartan or irbesartan have been recalled. The FDA has an ongoing list of the valsartan medications that have been recalled, a list of the valsartan medications that have not been recalled, and a list of the irbesartan products under recall.
If your medication is on either of the recall lists, the FDA suggests that you take it until your doctor or pharmacist provides you a replacement. Not all valsartan and irbesartan drugs are on the recall, so you may be able to switch to another company’s version.
It is currently unknown what the cancer risk is if the contaminated pills are taken, however, the FDA believes the risk is low with the valsartan medications.
The FDA has estimated that if 8,000 people took the recalled valsartan dose (320 mg) daily for four years, there could be one additional case of cancer over the lifetimes of the 8,000 people.
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