Blood Pressure Recall 2019: Another 87 Lots Recalled For Cancer-Causing Impurity

Posted March 06, 2019

The Food and Drug Administration has expanded an already widespread recall of common blood pressure and heart failure medications. NMBA had not been found in previously recalled ARB products, but the FDA continues its investigations.

"That said, any presence of such impurities in drug products is not acceptable", FDA Commissioner Scott Gottlieb said in the statement.

The agency's latest alert includes drugs that contain a potentially carcinogenic "impurity", though no adverse effects related to the recall have been reported.

On Thursday, the FDA announced Camber Pharmaceuticals is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg and 100 mg because NMBA was detected in a pharmaceutical ingredient of the product.

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AurobindoPharma, which is based out Hyderabad, India, distributed its tainted products to US pharmacies under the names of AurobindoPharma USA and Acetris Health LLC.

But patients should speak with their doctor to discuss the recall before they stop taking the drug.

Camber's recall dwarfs the one by Macleods, as it involves various sizes of tablets (25mg, 50mg 100mg) in various sizes of bottles (30-count, 90-count, 500-count, 1,000-count).

This adds to the list of blood pressure medications recalled since October.

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U.S. health regulators said on Friday a third cancer-causing toxin was found in some blood pressure pills recalled by India's Hetero Labs Ltd a day earlier, adding to a global recall of commonly used drugs to treat hypertension.

A full list of lot numbers and expiration dates can be found here.

You can also find more information about the recall at this link.

That impurity is N-nitrosodiethylamine (NDEA), which is classified as a "probable human carcinogen". The company also makes losartan for other Indian drugmakers, including Torrent Pharmaceuticals Ltd. and Macleods Pharmaceuticals Ltd., that has been recalled for containing NDEA.

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"Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA".