Valsartan Recall: FDA Adds More Firms in Recall of Blood Pressure Drug

Jack Phillips
By Jack Phillips
August 13, 2018USshare

More companies were added to a U.S. Food and Drug Administration recall of blood pressure and heart medicine containing a possible carcinogen, according to an update on Aug. 8.

Valsartan, according to the FDA, is used as a component in drugs that is to treat high blood pressure as well as congestive heart failure. The FDA initiated its first recall July 13 after tests showed the drugs could contain N-Nitrosodimethylamine (NDMA).

The Aug. 8 recall update includes Valsartan tablets from pharmaceutical companies AvKare, A-S Medication Solutions LLC, Bryant Ranch Prepack Inc, Camber Pharmaceuticals, Inc. H. J. Harkins Company, Northwind Pharmaceuticals, NuCare Pharmaceuticals Inc., Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC), Proficient Rx LP, RemedyRepack, Teva Pharmaceuticals (labeled as Major Pharmaceuticals), Teva Pharmaceuticals USA (labeled as Actavis).

A list of the drugs can be accessed on the FDA’s website, which can be accessed here (pdf).

The FDA said in a statement on Aug. 9, that it has “updated the list of valsartan products under recall and the list of valsartan products not under recall to incorporate recalls of valsartan-containing products manufactured by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals Inc. Not all Camber valsartan products distributed in the U.S. are being recalled.”

“Camber Pharmaceuticals is recalling certain valsartan tablets because they contain the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API). Hetero Labs manufactures the API for the Camber products using a process similar to Zhejiang Huahai Pharmaceuticals. Test results from Hetero Labs show the amount of NDMA found in its valsartan API exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang,” according to the agency.

On Aug. 2, the FDA added more valsartan-containing drugs to its recall list.

(Remains/iStock)
(Remains/iStock)

Made in China

The Epoch Times previously reported that the most of the valsartan-containing drugs were manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China.

NDMA, according to the Environmental Protection Agency (EPA), was once used to make rocket fuel, antioxidants, and softeners for copolymers. It isn’t used for anything other than for research.

China’s National Health Commission said that the recalled drug, which is used to treat patients with high blood pressure, shouldn’t be used for the diagnosis and treatment of diseases, Reuters reported on July 30.

The Chinese regime’s health regulator also said there were six local companies that used valsartan manufactured by Huahai. Five of the firms have issued recalls.

Rosemary Gibson, a senior adviser at The Hastings Center and an author of several books on health care issues, said that the tainted valsartan shows how defective medicines and pharmaceutical ingredients made by Chinese manufacturers are becoming a health hazard for other countries.

“There is a lack of trust in medicines made in China now,” Gibson told The Epoch Times earlier in July. “The public wants their medicine to be safe. This carcinogen hidden in valsartan raises the question whether other products that are made in China have been made contrary to the global standard we came to accept.”

The U.S.–China Economic and Security Review Commission said in an annual report (pdf) published in January that China has been a “prolific source” of defective and counterfeit drugs. “Chinese consumers may prefer U.S. pharmaceutical products due to concerns over the quality of domestic drugs. China has been a prolific source of counterfeit and defective medicine. In 2012, Chinese authorities seized 77 million domestically produced gel capsules that were created from industrial waste and contained excessive levels of cadmium,” the report said.

The U.S. National Library of Medicine also noted China’s drug problems.

“China has significant gaps and weaknesses in its regulatory oversight of the off-label use of drugs,” its website says.  “As in the United States, the off-label prescribing of drugs is not prohibited in China if there is a sound scientific basis.”

From The Epoch Times

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