Recalls

Camber recalls ARB losartan due to cancer causing impurity

ucm632396 375x146 Camber recalls ARB losartan due to cancer causing impurityCamber Pharmaceuticals Inc., is recalling 87 lots of its high blood pressure and heart failure medication losartan because the drug is contaminated with a potential human carcinogen. Camber is one of three companies to recall the drug lorsartan, and one of several to issue recalls involving high blood pressure drugs from a class known as ARBs, or angiotensin II receptor blockers.

The recalled Camber products include losartan packaged in 30, 90, 500 and 1000-count bottles. A full list of Camber’s recalled losartan medications can be found on the company’s news release.

The impurity detected in the drugs is called N-Nitroso N-Methyl 4-amino butyric acid (NDMA). The active pharmaceutical ingredient (API) was manufactured by Hetero Labs Limited. The Environmental Protection Agency (EPA) considers NDMA a possible carcinogen. It can unintendedly make its way into manufacturing through certain chemical reactions.

Beginning in July, several lots of the ARB drug valsartan were recalled after NDMA was detected in various brands. The FDA expanded its recall to other types of ARBS, which resulted in more recalls of valsartan, as well as the ARBs irbesartan and losartan.

“FDA previously estimated that if 8,000 people took the highest valsartan dose (320 mg) containing NDMA from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of the 8,000 people,” the agency said in a news release. “That estimate was based on the highest daily dose; however, many people may have taken lower doses, and therefore their risks would theoretically be less.”

Sources:
FDA
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