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Blood pressure medication recalled over risk of cancer-causing impurity – Portland, Oregon

Portland, Oregon 2021-10-19 14:58:48 –

Lupin Pharmaceuticals Inc. is recalling irbesartan and hydrochlorothiazide tablets after analysis revealed that certain API batches contained higher than acceptable levels of the impurity N-nitrosoyl vesartan. .. (Adam Berry / Getty Images)

(NEXSTAR) – Lupin Pharmaceuticals Inc. is voluntarily recovering blood pressure drugs that may contain high levels of impurities that cause cancer. US Food and Drug Administration..

The company said that after analysis revealed that certain API batches contained the impurity N-nitrosoyl besartan (probably a human carcinogen) at levels above specification limits, with irbesartan at the consumer level. We are recalling hydrochlorothiazide tablets.

Lupine recalls all batches of Irbesartan Tablets USP 75mg, 150mg, 300mg, Irbesartan Tablets, Hydrochlorothiazide Tablets USP, 150mg / 12.5mg, 300mg / 12.5mg in the United States.

Batches of tablets were packaged in 30-count and 90-count bottles and distributed throughout the United States to wholesalers, drug chains, mail-order pharmacies, and supermarkets.

Lupine discontinued sales of irbesartan and irbesartan and HCTZ tabs in January 2021.

Lupine has not received reports of any illnesses that may be related to this issue and is recalling the product “with great care”.

Pharmaceutical companies notify wholesalers, distributors, drug chains, mail-order pharmacies and supermarkets via telephone and recall notices and arrange for returns of all affected products in accordance with the recall notices.

Patients taking the drug are advised to continue taking the drug and contact their pharmacist, doctor, or healthcare provider for advice on alternative treatments.

Blood pressure medication recalled over risk of cancer-causing impurity Source link Blood pressure medication recalled over risk of cancer-causing impurity

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