Blood pressure medicine recalled after potential carcinogen is found in it

Randy Kelley
March 6, 2019

Prinston Pharmaceutical identified China's Zhejiang Huahai Pharmaceuticals as the source of NDEA found in its hypertension medication recalled by the company last month.

The factory at the center of the latest recall, Hetero Labs of India, has received warnings from the FDA, and reportedly shredded documents before inspection.

The U.S. Food and Drug Administration weighed in on the recalls of multiple generic angiotensin II receptor blocker, or ARB, drugs, on Friday, saying the impurities may be the result of chemical reactions that occur in the drugmaking process or from the reuse of materials, such as solvents.

Starting in July, separate lots of ARB blood pressure and heart failure medications from various companies were recalled around the world, including in the United States, due to containing similar impurities that are potential or suspected human carcinogens: N-nitrosodimethylamine or NDMA and N-nitrosodiethylamine or NDEA.

Camber said in a statement on Thursday that it was recalling 87 lots of losartan tablets due to the discovery.

There have been higher than a dozen recollects of variations of the blood stress and coronary heart drugs losartan, valsartan, and irbesartan that contained hint quantities of possible carcinogens. A full record of recalled drugs is offered from the FDA. NMBA is considered a potential cancer-causing ingredient in humans.

Regarding how the recall has affected patients and pharmacists, "most patients have to come in and get their medications changed out" to lots of medication that have not been affected, Freeman said. "The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future". FDA scientists have developed novel and sophisticated testing methods specifically created to detect and measure N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities in ARB medicines. Friday, Torrent recalled 60 lots of Losartan potassium tablets and 54 lots of Losartan potassium/hydrochlorothiazide tablets because of NMBA's presence. Incidentally, Hetero Labs Limited was also listed as the source of the contamination in both recalls.

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