The recalled 25 mg, 50 mg, and 100 mg tablets contained small quantities of N-Nitroso N-Methyl 4-aminobutyric acid, or NMBA, following a firm recall notice posted on the Food and Drug Administration's website.
This is the latest of more than 30 blood pressure medicine recalls.
In the latest such case, Camber Pharmaceuticals on Thursday recalled 87 lots of Losartan Potassium, a prescription drug used to treat high blood pressure and congestive heart failure. Friday, Torrent recalled 60 lots of Losartan potassium tablets and 54 lots of Losartan potassium/hydrochlorothiazide tablets because of NMBA's presence.
Certain lots of blood pressure and heart failure medications have been recalled from various companies worldwide since the U.S. Food and Drug Administration in July recalled valsartan medicines manufactured by the Chinese company Zhejiang Huahai Pharmaceuticals after detecting NDMA. The company said it hadn't received any reports of patients being harmed related to the recall. The affected Losartan tablets have expiration dates that range from September 2019 to June 2020.
The recalls began a year ago after regulators said ingredients used by Chinese manufacturer Zhejiang Huahai Pharmaceuticals Co to produce valsartan contained cancer-causing impurities.
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Camber's recall is the second in a week of Losartan tablets.
In a statement, FDA Commissioner Scott Gottlieb explained that the agency has been carrying out a series of investigations for several months after various companies began announcing their voluntary recalls.
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.
"FDA scientists have developed novel and sophisticated testing methods specifically created to detect and measure N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities in [angiotensin II receptor blocker (ARB)] medicines", Gottlieb wrote. In a recall announced a week ago, Macleods Pharmaceuticals also identified Hetero Labs as manufacturing the active ingredient containing N-nitrosodiethylamine, or NDEA, a probable human carcinogen.