FDA Continues to Expand Recall of Heart Drug Valsartan

The U.S. Food and Drug Administration (FDA) expanded on its recall of medications that contain valsartan, a blood pressure and heart failure prevention drug.

The FDA’s list (pdf) was updated on Aug. 27.

In July, the agency announced the recall of the drug when lab tests determined that it might be contaminated with a substance that can cause cancer.

The drugs being recalled are tablets sold by firms AvKare (Teva/Actavis) and (Hetero/Camber), A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco), Bryant Ranch Prepack Inc, (Teva/Actavis), Hetero Labs (labeled as Camber Pharmaceuticals Inc.), H J Harkins Co., Northwind Pharmaceuticals (Teva/Actavis), NuCare Pharmaceuticals Inc. (Prinston/Solco), Preferred Pharmaceuticals Inc. (Hetero/Camber), Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC), Proficient Rx LP, Remedy Repack, Remedy Repack (Prinston/Solco), Remedy Repack Inc. (Hetero/Camber), RemedyRepack Inc. (Torrent), Teva Pharmaceuticals (labeled as Major Pharmaceuticals), Teva Pharmaceuticals USA (labeled as Actavis), and Torrent Pharmaceuticals Limited.

N-nitrosodimethylamine (NDMA) was the impurity that was found in the lab tests, and it is considered carcinogenic by the Environmental Protection Agency (EPA).

The FDA also posted a list of drugs (pdf) with valsartan that have not been recalled.

The recalled medicine is linked to a drug manufacturer based in China. Zhejiang Huahai Pharmaceuticals, based in Linhai, supplied the substances.

“We published our recall notice at midday on July 13 in China and overseas, and published the US market recall notice on July 14 Beijing time ... all the drug materials for the Chinese market were recalled by July 23,” the company said in a statement last month, according to CNN.

In a statement on the FDA website, it said that it is working with drug makers “to ensure future valsartan active pharmaceutical ingredients are not at risk.”

“FDA reminds patients taking valsartan from a recalled lot that they should continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option. Not all valsartan products contain NDMA, so pharmacists may be able to provide a refill of valsartan medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition,” the FDA also said.

Chinese workers preparing to destroy fake medicines seized in Beijing, on March 14, 2013. The U.S. Food and Drug Administration announced on July 13, 2018, the recall of the heart medicine valsartan, made by Chinese firm Zhejiang Huahai, which was found to be contaminated by a carcinogen. STR/AFP/Getty Images

Tainted Chinese Drugs

“There is a lack of trust in medicines made in China now,” Rosemary Gibson, a senior adviser at The Hastings Center and an author of several books on health care issues, told The Epoch Times last month about the recall.

Zhejiang Huahai Pharmaceutical sold $50 million worth of valsartan in 2017 alone. It didn’t respond to The Epoch Times’ requests for a comment in last month’s report.

“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,” Gibson said. “We need to view medicine as a strategic asset, just like how we view oil and energy supply,” Gibson added. “A strategic asset is something that will make our country fall apart if we don’t have it.”