FDA Announces Voluntary Recall of Drugs Containing Valsartan

On Friday, July 13^th, FDA announced the voluntary recall of several drugs containing the active ingredient valsartan. Valsartan is often used to treat serious medical conditions such as high blood pressure and heart failure. However, in early July, the European Medicines Agency (EMA) recalled several drugs containing valsartan due to impurity concerns. N-nitrosodimethylamine (NDMA), a probable human carcinogen, was found in the recalled products.

According to a recent statement from the FDA, “the presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured. The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.”

Recalled Products

FDA has recalled five valsartan-containing medications:

1. Valsartan—Major Pharmaceuticals
2. Valsartan—Solco Healthcare
3. Valsartan—Teva Pharmaceuticals Industries Ltd.
4. Valsartan/Hydrochlorothiazide—Solco Healthcare
5. Valsartan/Hydrochlorothiazide—Teva Pharmaceuticals Lts.

However, it is important to note that not all products containing valsartan have been recalled. At this time, only valsartan supplied by Zhejiang Huahai Pharmaceuticals is being recalled. An updated list of FDA drug recalls can be found here.

Patient Information

In the FDA’s July 13^th news release includes information for patients and healthcare providers who use or provide valsartan-containing medication. According to the statement:

• Patients should contact a healthcare professional to discuss an alternative treatment plan, however, medication should continue to be taken until a replacement is prescribed.
• Patients should check the label of their prescription to determine if their medication is affected by the recall. If no information is available, they should contact their pharmacist.
• Patients taking medication affected by the recall should follow the recall instructions provided by the specific company.

Do you manufacture an FDA-regulated drug, medical device, or combination product? Do you want to ensure your product is in compliance with all FDA regulations and requirements? We can help.

The Weinberg Group can help you avoid a recall and confirm that your product and procedures meet all of the Agency’s standards.  Contact us today to learn more about our services and how we can help you with any and all of your quality and compliance related needs.