Tests found trace amounts of potentially cancer-causing chemicals in yet another recall of a blood pressure medication and the FDA is reportedly overwhelmed by the sheer number of investigations they are now carrying out in factories across China and India.
A substance that was previously used as an oil lubricant in motor engines, is now appearing in these harmful prescription drugs. Whilst other heart medication can actually increase your blood pressure.
If you take blood pressure medicine, you’ll want to double-check the safety of these prescription drugs, as Torrent Pharmaceuticals Ltd. has expanded its recall of Losartan potassium and losartan potassium/hydrochlorothiazide tablets.
Tests found trace amounts of a potentially cancer-causing impurity called N-methylnitrosobutyric acid in some of these drugs. The company is recalling 36 additional lots it said this week.
A full list of recalled drugs is available on the US Food and Drug Administration website.
The FDA is reported to be overwhelmed with cases
This latest recall is related to the valsartan recall that has been expanded multiple times since July. The FDA put the Chinese company Zhejiang Huahai Pharmaceutical on an import alert after it learned that the company made the tainted ingredient that is at the heart of most of these recalls. The impurity is a chemical that is used in gasoline as a stabilizer and as a lubricant additive.
As we reported back in January of this year The FDA also started testing all heart drugs called angiotensin II receptor blockers for these impurities. Also known as ARBs, they block a potent chemical in the blood called angiotensin that causes muscles surrounding blood vessels to contract. When the chemical binds, it narrows the vessels, and that can cause high blood pressure.
Factory inspections of facilities in China and India in recent months have revealed a pattern of issues regarding drugs valsartan, losartan and irbesartan, either alone or in combination with other drugs.
Another recent recall involves eight lots of irbesartan manufactured by Zhejiang Huahai Pharmaceuticals.
“I think we have a federal agency that is overwhelmed in trying to keep up,” Public Citizen researcher and director Michael Carome told USA Today, noting the FDA often prioritizes inspections based on potential risk.
The agency has been examining “a backlog of unchecked foreign drug plants” amid the increasing overseas pharmaceutical industry actors, including China’s Zhejiang Huahai Pharmaceutical and India’s Hetero Labs, both of which have been forced to recall carcinogen-tainted drugs.
But exacerbated inspection policies, investigations or recalls don’t guarantee prevention or action from drug companies to correct the problems.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told USA TODAY the agency isn’t running those manufacturing plants. “Really, a lot of responsibility is on the people who manufacture and offer these drugs for sale,” she added.
India’s Hetero Labs has had to recall several commonly prescribed blood pressure drugs since July, including versions of losartan, valsartan and irbesartan.
The Sandoz Inc. recall involved 100 milligram/25 milligram Losartan tablets with the lot number JB8912 and expiration date of June 2020. The affected product was not distributed prior to Oct. 8, 2018, according to the FDA.
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