Drug Impurity Woes Worsen as Lupin Recalls Some Pills in U.S.
Drug Impurity Woes Worsen as Lupin Recalls Some Pills in U.S.
(Bloomberg) -- A unit of Indian drugmaker, Lupin Ltd., issued a voluntary U.S.-wide recall for some batches of two blood pressure pills over concerns about potentially carcinogenic impurities.
Lupin Pharmaceuticals Inc. issued a recall for Irbesartan tablets and Irbesartan and Hydrochlorothiazide tablets after its analysis revealed that some batches of these drugs had more than permitted levels of N-nitrosoirbesartan, a probable carcinogen, the company said in a statement to exchanges.
Sanofi also recalled certain drugs containing Irbesartan in Canada in June for elevated levels of azido impurities, which are mutagenic -- meaning they can change someone’s DNA and potentially increase cancer risk. It sold some of those same drugs in the U.S.
Lupin’s drug recall comes after millions of blood pressure pills have been pulled off shelves by various drugmakers in the past three years for containing another probable carcinogenic chemical called N-Nitrosodimethylamine. Meanwhile, azido impurities were also found in similar pills that were recalled in Europe earlier this year.
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