Blood Pressure Drugs Recalled For Potentially Elevated Carcinogen Levels

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October 18, 2021 – Two types of hypertension drugs manufactured by Lupine Pharmaceuticals have been recalled due to potentially high levels of a carcinogen, according to a FDA Recall Notice.

The company is voluntarily recalling all batches of irbesartan tablets in strengths of 75 milligrams (mg), 150 mg and 300 mg, as well as irbesartan / hydrochlorothiazide tablets in 150 mg / 12.5 mg and 300 mg / 12, 5 mg strengths.

Lupine said he stopped marketing the tablets in January. Both types are used to treat hypertension or high blood pressure.

Analysis during the company’s testing process showed that some tested lots – but not finished product lots – were above the limit for N-nitrosoirbesartan, an impurity that can cause cancer.

“Although Lupine has not received any reports of illness that appear to be related to this issue, the company, out of caution, is recalling all batches,” according to the advisory.

The company received four illness reports with irbesartan tablets and no illness reports with irbesartan / hydrochlorothiazide tablets between October 8, 2018 and September 30, 2021, which includes the first date of shipment from the site. manufacturing process for any of the affected products. lots. The four illnesses were unrelated to the impurity, the company said.

The recall notice includes the lot numbers of the 30- and 90-unit bottles that went to US wholesalers, drug chains, mail-order pharmacies and supermarkets across the country between 2018 and 2020. Lupine is hosting the return of all batches of recalled products.

People taking these tablets should continue to take their medicine and contact their pharmacist or doctor to arrange a different treatment, depending on the advice.

People can report side effects or quality issues to the FDA MedWatch Adverse Event Reporting Program, either online, by mail or by fax. Instructions are included in the recall notice.


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