Lupin recalls 2 hypertension drugs in US due to potential impurity

Drug firm Lupin on Thursday said its US-based arm is voluntarily recalling all batches of two hypertension drugs due to potential presence of a substance that could cause cancer.
The company in a statement said that Lupin Pharmaceuticals Inc is voluntarily recalling lrbesartan tablets and lrbesartan and Hydrochlorothiazide tablets to the consumer level.
The tablets have been recalled due to potential presence of N-nitrosoirbesartan impurity, a substance that could cause cancer.
“As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” it added.
Although the company has received no reports of illness that appear to relate to this issue, out of an abundance of caution it is recalling all batches of lrbesartan tablets USP 75mg, 150mg and 300mg and lrbesartan and Hydrochlorothiazide tablets USP, 150mg/12.Smg and 300mg/12.5mg in the US, Lupin …