Lupin Pharmaceuticals issued a voluntary recall of blood pressure medications following tests on API batches that indicated possible contamination with cancer-causing impurities.
The voluntary recall is posted on the FDA’s website and involves the company’s irbesartan and hydrochlorothiazide tablets used to treat high blood pressure and diabetic nephropathy in hypertensive patients with Type 2 diabetes.
“As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above specification limit for the impurity, N-nitrosoirbesartan,” the agency said.
Between early October 2018 and the end of September this year, Lupin received four reports of illness from irbesartan but no reports of illness from the combination irbesartan and hydrocholorothiazide tablets. Irbesartan tablets—distributed in 75-mg, 150-mg and 300-mg forms—were distributed nationwide in the U.S. through wholesalers, drug chains, mail order pharmacies and supermarkets.
N-nitrosoirbesartan is considered an impurity that could cause cancer in humans.
Back in the summer of 2020, Lupin was among a slew of companies including Sun Pharma, Bayshore Pharmaceuticals and Granules Pharmaceuticals that pulled the generic diabetes medication metformin because of probable carcinogen contamination in tested batches.
Those recalls were in response to the FDA finding high levels of N-nitrosodimethylamine earlier in the year that triggered global recalls of “sartan”-based blood pressure drugs and heartburn medications such as Zantac.