FDA Expands Valsartan Recall List to Include More Manufacturers

On July 13, 2018, the FDA announced a voluntary recall of medications containing “valsartan,” a high-blood-pressure drug that was found to be contaminated with an impurity classified as a possible carcinogen. Not all drugs were recalled—only those containing valsartan supplied by Zhejiang Huahai Pharmaceuticals from Linhai, China.

Then on August 9, 2018, the FDA updated its list of valsartan products under recall, incorporating several additional manufacturers.

FDA Recalls Some Medications Containing Valsartan

Valsartan belongs to a class of drugs known as “angiotensin receptor blockers (ARBs).” These drugs block the angiotensin-converting enzyme (ACE), which usually causes blood vessels to narrow or constrict. By blocking the action of this enzyme, the drug helps keep the blood vessels relaxed and open, allowing blood to flow through more easily. This can help relieve high blood pressure and is also effective in patients with congestive heart failure, or those who are at risk for heart attacks or strokes.

Many current medications on the market include valsartan, but not all are affected by the recall. Initially, the FDA recalled only generic versions of the drug made by Major Pharmaceuticals, Teva Pharmaceuticals, and Solco Healthcare.

Europe First to Recall Medicines Containing Valsartan

Chinese manufacturer Zhejiang Huahai Pharmaceuticals is one of the valsartan manufacturers, and they initially found the impurity which is called “N-nitrosodimethylamine (NDMA)”. It is a chemical that forms as a byproduct of some industrial processes. The FDA noted that Zhejiang Huahai made changes to its manufacturing process in 2012 that may have caused the unintentional production and release of the impurity.

The FDA has also noted that they “are still not 100 percent sure that this is the root cause of the problem.” To make a determination as to the root cause of the contamination, the FDA stated it “…will require correlation of multiple test results from valsartan made by different processes with the various process steps used by different manufacturers or at different times.”

The Environmental Protection Agency (EPA) has classified NDMA as a probable human carcinogen based on animal studies in which subjects were exposed to large doses, and suffered an increased risk of tumors in the liver, respiratory tract, kidneys, and blood vessels.

The European Medicines Agency (EMA) was the first to take action on the drug, recalling all medicines containing it in May 2018. The FDA followed suit in July 2018. Both agencies noted that they would continue to investigate the issue and provide updates as needed.

FDA Adds New Manufacturers to Recall List

The FDA has now added several more companies to the list of those that have products under recall. In addition to the three listed above, as of August 8, 2018, the following manufacturers have been included:

• AvKARE
• Remedy Repack
• A-S Medication Solutions LLC
• Bryant Ranch Prepack Inc.
• H J Harkins Company (dba Pharma Pac)
• Proficient Rx LP
• Northwind Pharmaceuticals
• Camber Pharmaceuticals, Inc.
• NuCare Pharmaceuticals, Inc.

Then on August 8, 2018, the FDA added Hetero Labs, Limited, in India, labeled as Camber Pharmaceuticals Inc. The FDA noted that Hetero Labs manufactures the drug for Camber products “using a process similar to Zhejiang Huahai Pharmaceuticals.” Tests from the manufacturer showed that the amount of NDMA found in its valsartan was higher than the acceptable limits.

The FDA continues the investigation, and advises patients to check the drug name and company name on the labels of their prescription bottles. Those who have a recalled product should follow the recall instructions given by that company, or check with the FDA’s website for more information.