Lupin Pharmaceuticals Issues Nationwide Recall of All Irbesa
Lupin pharma has voluntarily recalling batches of irbesartan and irbesartan/hydrochlorothiazide tablets. The decision was taken after an analysis revealed that certain tested active pharmaceutical ingredient batches had too much N-nitrosoirbesartan. 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 of Irbesartan Tablets USP 75 mg, 150 mg and 300 mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg/12.5 mg and 300 mg/12.5 mg in the US. Lupin discontinued the marketing of the tablets in January 2021 as N-nitrosoirbesartan impurity is a probable human carcinogen. The company has received four reports of illness from irbesartan and none from irbesartan and hydrochlorothiazide. The FDA advised that patients taking irbesartan or irbesartan/hydrochlorothiazide tablets continue taking their medication and to contact their pharmacist, physician or medical provider for advice regarding an alternative treatment.

If you find this research insightful, please like, comment and share.

For more details, please read:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-all-irbesartan-tablets-and-irbesartan
R●●●n P●●●l and 7 others like this1 share
Like
Comment
Share