Valsartan Recall

The U.S. Food and Drug Administration (FDA) has asked for a voluntary recall of valsartan (which was formerly known as Diovan before the drug changed to generic formulation).   Valsartan is used to treat high blood pressure and heart failure.

 

The recall is not due to the valsartan itself raising a concern for cancer risk.

This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products.  It is important to note that not all products containing valsartan are being recalled.  NDMA is listed as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.  The contamination of the generic valsartan medications with NDMA was unexpected and believed to be due to changes in the way the medication was manufactured.

 

It is important to note that not all formulations of valsartan are affected by this recall.  We recommend that patients call their pharmacist to discuss whether or not their medication is included in the recall.  Patients currently taking Entresto (sacubitril/valsartan) for heart failure are not included in this recall.

 

 

Recommendations for patients:

 

1.  Because valsartan is used in medicines to treat serious medical conditions (high blood pressure and heart failure/cardiomyopathy), patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.

 

2.  To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.  Their physicians and care-givers will not likely know the source of their medication.  It is best for the patient to contact their pharmacy directly.

 

3.  If a patient is taking valsartan from one of the companies listed below, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA's website:  https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm

 

 

4.  Patients should contact their pharmacist if their medicine is included in this recall to discuss alternate sources of their medication that are not included in the recall.  Alternatively, patients may contact our office to discuss a different medication.  It is important to note that a change to another medication may result in a different price at the pharmacy and/or need to have dosing adjustments to provide the same degree of blood pressure control.

 

 

The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan.

 

 

Recalled Products

 

Medicine

Company

Valsartan

Major Pharmaceuticals

Valsartan

Solco Healthcare

Valsartan

Teva Pharmaceuticals Industries Ltd.

Valsartan/Hydrochlorothiazide (HCTZ)

Solco Healthcare

Valsartan/Hydrochlorothiazide (HCTZ)

Teva Pharmaceuticals Industries Ltd.

 

 

This release has been adapted from information at www.fda.gov and www.prnewswire.com

 

 

 

 

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