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October 15, 2021October 14, 2021 – Lupin Pharmaceuticals has recalled all batches of its Irbesartan Tablets USP 75mg,150mg, and 300mg in the United States, as well as all batches of Irbesartan and Hydrochlorothiazide (HCTZ) Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the U.S. The company has identified an impurity, N-nitrosoirbesartan, that exceeds the specified limit.
- There is no impact to members through Benecard Central Fill.
- Lupin stopped marketing Irbesartan and Irbesartan/HCTZ tablets in January 2021.
- Irbesartan is indicated to treat high blood pressure (hypertension) and diabetic nephropathy, while Irbesartan/HCTZ is indicated only for treatment of hypertension. N-nitrosoirbesartan is a probable human carcinogen that could cause cancer.
- As of the recall date, Lupin has received four reports of illness from the affected batches of irbesartan and no reports for irbesartan/HCTZ.
- Questions regarding this recall and requests for reimbursement should be directed to Inmar Rx Solutions at 1-855-769-3988 or 1-855-769-3989.
- The full recall notice, including affected lot numbers, can be found on the U.S. FDA's website.