FDA Recalls Certain Batches of Valsartan

The FDA has recalled certain batches of the blood pressure and heart medicine Valsartan due to impurity.

Hudson River Health Care is committed to providing the highest quality care to our patients, and keeping them abreast of information that may impact their health. On June 27, 2018, there was a recall of the medication Valsartan API in several countries outside of the United States: Germany, Norway, Finland, Sweden, Hungary, The Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, Luxembourg, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain, and Malta. The recall was due to an impurity of N-Nitroso-dimethylamine (NDMA), which can be harmful. The recall did not affect medications in the United States originally.

On July 13, 2018, the United States Food and Drug Administration (FDA) announced a separate recall of certain batches of Valsartan from non-Sondoz companies. On July 27, 2018, the FDA expanded the list of manufacturers included in the recall.

Click here for a full list of medications included in the recall, and click here for a list of products not included in the recall.

For more facts about NDMA, click here.

If you have any questions or concerns, please schedule an appointment with your primary care provider.



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