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More than 30 lots of losartan drug products have been recalled due to contaminated API manufactured by Hetero Labs.
In the latest recall of angiotensin II receptor blocker (ARB) recalls, Macleods Pharmaceuticals Limited initiated a voluntary recall of 32 lots of drug products that contained API manufactured by Hetero Labs Limited. The drugs contained trace amounts of the impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) that were above FDA’s interim acceptable exposure limit of 9.82 ppm.
The products include losartan potassium USP tablets and losartan potassium/hydrochlorothiazide combination tablets.
The recall was issued on June 25, 2019. The company reports that to date, it has not received any reports of adverse events related to the recall.
In July 2018, FDA first alerted the public about a recall of generic valsartan drugs containing an impurity, N-nitrosodimethylamine, a probable human carcinogen. Subsequent investigation has led to widespread recalls of other ARB drugs due to NDMA and other contaminants. FDA has published exposure limits and analytical tests to evaluate drug products for the impurities.
A summary of recalls and agency action is available on the FDA website.