FDA Drug Recall: Valsartan Blood Pressure Medications :

July 24,2018

Multiple drug companies have been named in the FDA Drug Recall of generic medications used to treat heart failure and high blood pressure. According to the U.S. Food and Drug Administration, the voluntary recall came as companies discovered their medicines contained traces of N-nitrosodimethylamine (NDMA), which has been linked to human carcinogens as a probable cancer-causing agent. The FDA announced the drug recall in mid-July and twenty two other countries have followed suit and issued recalls on products containing valsartan. The three drug companies named so far by the FDA include Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. for medications containing valsartan and valsartan/hydrocholrothiazide (HCTZ).

Solco Healthcare Recall

Prinston Pharmaceutical (dba Solco Healthcare) is recalling all lots of valsartan tablets manufactured by Zhejiang Huahai, which includes:

• Valsartan - 40mg, 80mg, 160mg and 320mg
• Valsartan-HCTZ Tablets - 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg

Recall includes all medicines with an expiration date range from July 2018 to January 2020. You are asked to return the product to your pharmacy immediately.

Major Pharmaceuticals Recall

According to Major Pharmaceuticals, their valsartan products were distributed to both wholesale and retail providers nationwide. This includes both pharmacies and hospitals.

Teva Pharmaceuticals Recall

Impacted medications supplied by Teva Pharmaceuticals for both valsartan and valsartan-combination drugs including:

• Valsartan 80mg tablets and 160mg talbets
• Valsartan combination medicines for 51 lots

These were manufactured by Zhejiang Huahai Pharmaceutical and distributed under the Actavis brand. Patients should take immediate actions to follow the FDA Recall Guidelines as well as contact their healthcare provider.

NOTE: The drug valsartan is not the problem and patients should not lose faith in this important heart drug. All recalled medications are generic versions of the brand name Diovan, which is made by Novartis International AG. Diovan (brand name) and other generic versions from other manufacturers are not included in the recall. According to a spokesperson for the FDA's Center for Drug Evaluation and Research, these medical products did not meet the FDA's current safety standards. It should be noted that not all valsartan-based products sold in the United States have been impacted by the contamination. The medications being recalled are all linked to a Chinese pharmaceutical manufacturer, Zhejiang Huahai Pharmaceutical. Consumers can report adverse reactions and other health-related issues to the FDA through the U.S. Food and Drug Administration's MedWatch Adverse Event Reporting program, which can be reached via phone, fax, by regular mail, or online.