Published: Tue, March 05, 2019
Health Care | By Cedric Leonard

Another blood pressure drug recalled due to cancer risk

Another blood pressure drug recalled due to cancer risk

The impurity is a known animal and potential human carcinogen. Other companies to announce recalls include Maylan, Aurobindo Pharma and Torrent Pharmaceuticals, which also listed Hetero Labs as the source of the contamination in its recall.

The U.S. Food and Drug Administration said Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets due to detection of trace amounts of an unexpected impurity. Hetero Labs Ltd.in India has already announced a recall of 87 lots of losartan potassium tablets (25 mg, 50 mg and 100 mg).

Each company noted it has not received any reports of adverse events related the recall.

The remedy is packaged in 30 rely upon, 90 depend, 500 depend and 1000 rely on bottles.

The affected Losartan tablets have expiration dates that run from September 2019 through June 2020.

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Camber's recall is the second in a week of Losartan tablets. 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 active drug ingredient was made at Hetero Labs Restricted in India, one in all two overseas drug factories linked to repeated blood treatment recollects since final July. 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.

"Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA".

The FDA said in a statement it was investigating the formation of these impurities, which were reported to be made by previously unknown to drug developers.

You can find the list of lot numbers recalled by Camber Pharmaceuticals here.

Camber and Macleods are among the half dozen pharmaceutical firms that have recalled hypertension drugs found to contain possible carcinogens since early December.

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