Net Widens for Companies Over Tainted Valsartan Recalls

Patrice Wendling

July 30, 2018

Three companies that repackage drug products are recalling valsartan-containing medicines, and  more companies are expected to follow suit, according to the US Food and Drug Administration (FDA).

Valsartan-containing products made by Teva Pharmaceuticals and Prinston Pharmaceutals — labeled as A-S Medication Solutions, AvKARE, and RemedyRepack — have been added to the list of recalled products.

The agency is working to confirm whether A-S Medication and Remedy Repack also may distribute valsartan products not affected by the recall, it writes in a July 27 update.

Valsartan is commonly used to treat hypertension and heart failure and has been the subject of global concern after N-nitrosodimethylamine (NDMA), a probable human carcinogen, was found in the active pharmaceutical ingredients (APIs) manufactured by Zhejiang Huahai Pharmaceuticals, Linhai, China.

The state-run Chinese news agency, Xinhua, is reporting that the company "has taken needed measures in line with regulations" and has halted shipments and launched voluntary recalls in domestic and foreign markets.

According to Xinhua's July 29 report, the State Drug Administration "has screened all of the country's seven Valsartan API suppliers including Huahai for NDMA, qualifying products of the other six makers."

This is the second medical scandal to hit China, after a vaccine maker was found to have falsified data and sold faulty vaccines for children.

While Zhejiang Huahai has stopped distributing its valsartan API. "Some levels of the impurity may have been in the valsartan-containing products for as long as four years," the FDA previously reported.

"FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there may be one additional case of cancer over the lifetimes of these 8,000 people. This assessment led to FDA's decision to have these batches recalled," the agency writes.

European authorities issued a recall of medications containing valsartan supplied by the Chinese drug maker July 5, followed by a voluntary recall from Health Canada on July 9, and the FDA on July 13.

In its latest bulletin, the FDA lists six additional drug repackaging companies that "are recalling or are expected to recall valsartan-containing products." They are:

  • Bryant Ranch Prepack Inc;

  • H.J. Harkins Co.  (this company was not originally included on either the recalled or not-recalled product lists);

  • Lake Erie Medical, doing business as Quality Care Products LLC;

  • NuCare Pharmaceuticals Inc;

  • Northwind Pharmaceuticals; and

  • ProficientRx.

"FDA is working to gather product recall information from these companies and has removed them from the list of products that are not impacted by this recall," the agency notes in the July 27 update.

"It is possible that not all valsartan-containing products repackaged by these companies are impacted by the recall," the statement adds. 

The agency will update the list of products subject to the recall and the list of products not currently recalled as more information becomes available.

More information on the valsartan recalls is available on the FDA website.

Follow Patrice Wendling on Twitter: @pwendl. For more from | Medscape Cardiology, follow us on Twitter and Facebook.


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