FDA Clarifies Recall of Valsartan Products Supplied by China’s Zhejiang Huahai Pharmaceuticals

The US Food and Drug Administration (FDA) published updated information regarding the valsartan-containing product recall first identified on July 13th in a press release.

The FDA is recalling all lots of non-expired products that contain the ingredient valsartan, supplied by Zhejiang Huahai Pharmaceuticals, Linhai, China.

“We’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Valsartan is an ingredient used to treat high blood pressure and heart failure.  Certain products are being recalled due to an impurity, N-nitrosodimethylamine (NDMA), which was found in these recalled products. 

NDMA is classified as a probable human cancer-causing substance.

Manufacturers of these valsartan-containing products often produce multiple dosage strengths, however, not all of them are being recalled.

The FDA said it will continue to update the list of products included in the recall and the list of products not included in the recall.

Additionally, the FDA reminds consumers to continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option.

Untreated hypertension (high blood pressure) leads to an increase in the risk of heart attacks and stroke. Untreated heart failure increases the risk of hospitalization and death, said the FDA. 

“Pharmacy partners everywhere are working to contact their patients who potentially could have received the recalled medication,” said Jeremy H. Ashley, PharmD Clinical Pharmacist, Pharmacy Corporate Development Brookshire Grocery Company.

“Affected patients are encouraged to consult their physician regarding alternative hypertension treatment before stopping the medication,” said Ashley.

There are 3 voluntary recalls related to the NDMA impurity detected in the valsartan API: 

• Teva Pharmaceuticals USA labeled as Major Pharmaceuticals — recall is at the retail level because these products are only used in facilities where they are directly administered to patients by health care professionals: Valsartan 80 mg and 160 mg products;
• Prinston Pharmaceuticals Inc. labeled as Solco Healthcare LLC — recall is at the consumer/user level: Valsartan 40 mg, 80 mg, 160 mg, and 320 mg; and valsartan/HCTZ 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg products; and
• Teva Pharmaceuticals labeled as Actavis LLC — recall is at the consumer/user level: Valsartan 40 mg, 80 mg, 160 mg, and 320 mg; and valsartan/HCTZ 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg products.

Consumers and health care professionals should report any adverse reactions with valsartan-containing products, to the FDA’s MedWatch program to help the agency better understand the scope of the problem.