FDA Expands Recall of Blood Pressure, Heart Drug Valsartan

August 6, 2018 Updated: August 7, 2018

The U.S. Food and Drug Administration (FDA) says that it has expanded its voluntary recall of several medications used to treat high blood pressure and heart failure.

The FDA said that traces of N-nitrosodimethylamine were found in valsartan, the active ingredient in the drug, and it is known to cause cancer.

On Aug. 2, the FDA gave an updated list of the drugs that are included in the recall, and they include pills that were made around the world. The new list includes:

Valsartan – Prinston – Pharmaceutical Inc.

Valsartan – AvKARE

Valsartan – A-S Medication Solutions LLC

Valsartan – Bryant Ranch Prepack, Inc.

Valsartan – HJ Harkins Company

Valsartan – Major Pharmaceuticals

Valsartan – Solco Healthcare

Valsartan – Northwind Pharmaceuticals

Valsartan – Teva Pharmaceuticals USA labeled as Actavis

Valsartan – Teva Pharmaceuticals labeled as Major Pharmaceuticals

Valsartan/Hydrochlorothiazide (HCTZ) – Proficient Rx LP

Valsartan/Hydrochlorothiazide (HCTZ) – Remedy Repack

Valsartan/Hydrochlorothiazide (HCTZ) – Solco Healthcare

The agency said in a statement on Aug. 2: “[The] FDA continues to evaluate valsartan-containing products and has updated the list of products included in the recall and the list of products not included in the recall. In addition to updating the lists, FDA revised information related to A-S Medication on the list of products included in the recall. The agency will continue to provide information when it becomes available.”

The FDA also provided a list of drugs that are not included in the recall, which can be accessed here.

“FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients (APIs) are not at risk of NDMA formation. The agency reminds manufacturers to thoroughly evaluate their API manufacturing processes, and changes to those processes, to detect any unsafe impurities. If a manufacturer detects new or higher levels of impurity, they should take action to prevent changes to the product’s safety profile,” said the FDA.

 

Chinese-Made Drug

The first recall notices were issued on July 13 that 29 types of single and 51 types of combination valsartan medicines are being recalled. Later, the European Medicines Agency (EMA) announced a recall of the drug on July 5 when it was informed by China’s Zhejiang Huahai Pharmaceutical—a major global manufacturer of generic valsartan—that the drug had been contaminated.

The recall highlights how defective medicines and pharmaceutical ingredients made by Chinese companies can be a health hazard in the United States and in other parts of the world.

“There is a lack of trust in medicines made in China now,” Rosemary Gibson, a senior adviser at The Hastings Center, told The Epoch Times in July.

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“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 also stated in an annual report published in January 2018 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 commission’s report noted.

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