Take Charge

Recall of Heart, Blood Pressure Medication Grows

August 22, 2018

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By Steve Blanchard

A worldwide recall of common blood pressure medication valsartan has expanded to yet another manufacturer. Torrent Pharmaceuticals Ltd. is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets because of trace amounts of the impurity N-nitrosodimethylamine, or NDMA.

NDMA is classified as a probable human carcinogen — a substance that could cause cancer. Those findings are based on results from recent laboratory tests and it is important to understand that the drug itself isn’t dangerous, just the impurities found in some specific manufacturers.

It’s concerning, of course, but it should not prevent patients from taking the drug made by manufacturers not on the list.

“It’s not the drug that causes cancer,” said Moffitt cardiologist Michael Fradley. “The drug itself is quite good and important.”

Earlier this summer, the United States Food and Drug Administration singled out specific manufacturers of valsartan, which is used to treat high blood pressure and heart failure. This marks the third updated recall.  

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 or if they are unsure, patients should contact the pharmacy that dispensed the medicine.

NOTE: Visit the FDA website for full list of recalls including the lot numbers. 

Other valsartan tablets (dosages 40 mg to 320 mg) the FDA has recalled include products from the following drug companies:

  • A-S Medication Solutions (labeled as Solco Healthcare)
  • Bryant Ranch Prepack
  • HJ Harkins Company
  • Northwind Pharmaceuticals
  • Prinston Pharmaceutical Inc. (labeled as Solco Healthcare)
  • Teva Pharmaceuticals Industries Ltd. (some labeled as Actavis, some as Major Pharmaceuticals)

Recalled valsartan/hydrochlorothiazide tablets (dosages range from 80 mg/12.5 mg to 320 mg/25 mg) include products from these drug companies:

  • AvKARE
  • A-S Medication Solutions
  • Northwind Pharmaceuticals
  • Prinston Pharmaceutical (labeled as Solco Healthcare)
  • Proficient Rx
  • Remedy Repack
  • Teva Pharmaceuticals (some labeled as ACtavis)

Visit the FDA website for full list of recalls including the lot numbers.