All of the affected medicines have the active ingredient valsartan.
The FDA says Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., is voluntarily recalling all lots of Valsartan Tablets and Valsartan-Hydrochlorothiazide Tablets after unexpected traces of the impurity N-nitrosodimethylamine, or NDMA was found in certain batches of the medicine.
Studies on animals have shown NDMA can cause cancer in the liver, kidney, and respiratory tract. So far there have been no studies of the chemical’s effect on humans and the FDA said Prinston was unaware of any evidence that NDMA has resulted in any harm to patients taking the drugs subject to this recall.
So far, products from three companies – Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceutical Industries Inc. – are involved in the recall.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” explained Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
The list of recalled products includes: Valsartan – Major Pharmaceuticals, Valsartan – Solco Healthcare, Valsartan / Hydrochlorothiazide (HCTZ) – Solco Healthcare, Valsartan – Teva Pharmaceutical Industries Inc., Valsartan / Hydrochlorothiazide (HCTZ) – Teva Pharmaceutical Industries Inc
The FDA has issued a number of recommendations including to keep taking the drugs until they have a safe replacement.
Please share this important warning with your friends and family.