Recall On Popular Blood Pressure Medicine

Blood Pressure Medicine Recall

A known carcinogen found in a common blood pressure medication has prompted the FDA to announce a nationwide recall from several distributors of the popular drug used to treat high blood pressure and heart failure.

What Falls Under The Recall?

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. The Recall includes Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. Additional information regarding this recall affected products’ lots and expiry dates can be found at http://www.solcohealthcare.com/uploads/news/ValsartanHCTZRecallAffactedLots.pdf

Why Are The Medications Being Recalled?

This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

What Should You Do Next?

The FDA makes the following recommendations:

  • Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.
  • 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.
  • If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.
  • Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.

 

Read the Press Release from the FDA by clicking here.

Get more information from the FDA’s safety recall page, by clicking here.

2018-07-16T16:13:32+00:00July 16th, 2018|Defective Products|