The FDA announced a third heart medication recall. The agency found impurity N-nitrosodiethylamine (NDEA) in losartan potassium hydrochlorothiazide tablets. The International Agency for Research on Cancer warns that NDEA is a human carcinogen.
NDEA can exist naturally in certain foods and drinking water. However, it can also be in air pollution and industrial processes. Many industry materials also use it along with gasoline as a stabilizer. The International Agency for Research on Cancer warns that it can cause cancer in humans. Now, the FDA has pinpointed that NDEA in these heart medications was made by Zhejiang Huahai Pharmaceutical Company Co. Ltd. The FDA thus placed the Chinese company on an import alert at the end of September. This means all of its active pharmaceutical products and finished products will not be permitted to enter the United States. The FDA made that decision after an inspection of the facility.
Third Heart Medication Recall
The FDA’s newest heart medication recall involves Sandoz’ losartan potassium hydrochlorothiazide. The agency found NDEA in certain lots of the medication. Several pills that contain valsartan, another drug used by heart patients, have been under a recall since July. The drugs were tainted with NDEA or NDMA. Both are carcinogens. The FDA is testing all heart drugs (ARBs) for these impurities.
Furthermore, the losartan recall only involves the 100 milligram/25 milligram tablets. It does not involve the other versions of the drug, sometimes sold under the brand names Hyzaar. The bottle lot number is JB8912. If you have the recalled medication, please keep your medication for testing.
The U.S. Valsartan Recall
In July 2018, the FDA has asked three manufacturers of generic valsartan medication to voluntarily recall it from the U.S. market. Also, the agency asked pharmacists to return contaminated medications to the manufacturers. Furthermore, the agency is continuing to investigate the NDMA levels to asses cancer risks in those who already ingested the medication. the agency identified 13 other API manufacturers who supply more than 20 drug companies that make valsartan for the U.S. market. We made plans to determine if their products could also contain NDMA. Over 8,000 people received the highest dose of valsartan medications, and therefore the largest amount of the chemical.