Lupin Pharmaceuticals has recalled two types of blood pressure medicine due to potentially high levels of a carcinogenic substance.
All batches of its irbesartan tablets in 75mg, 150mg and 300mg strengths, and irbesartan/hydrochlorothiazide tablets in 150mg/12.5mg and 300/12.5mg strength are voluntarily being recalled by the company.
The company said it stopped marketing the tablets, which were used to treat hypertension or high blood pressure, in January.
According to an analysis done on certain, tested API batches, none of which were a part of finished product batches, were above the specified limit for the N-nitrosoirbesartan impurity.
“Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches …” the company said in a statement to the FDA.