The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party. Solco and Teva were also asked to recall their drugs containing valsartan/hydrochlorothiazide (HCTZ).
Patients taking these prescriptions to treat serious medical conditions should keep taking them until they have a replacement product. Patients who are on valsartan should continue taking their medication, as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
Zhejiang Huahai Pharmaceutical produces the active substance Valsartan.
The companies can manufacture and sale valsartan medicine made from valsartan raw material imported from other qualified sources, the statement said.
The FDA said not all products containing valsartan were being recalled in the United States.
A request for a class-action suit filed in the Montreal courthouse on Monday wants the manufacturers of a recalled heart medication, valsartan, to pay damages to Quebecers who took the drug. The FDA noted not all products containing valsartan are contaminated and being recalled. "The presence of of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured", the FDA release said.
"First and foremost, they need to call their pharmacy and make sure that the product they have is on the recall list", Scribner said.
To determine if a specific product has been recalled, look at the drug name and company name on the prescription bottle's label. Zhejiang Huahai Pharmaceuticals supplied the three US -based pharmaceutical companies with these products, according to The New York Times.
The FDA will continue its investigation into the drug.
Valsartan is also used for the treatment of heart failure, and is indicated as a treatment for left ventricular failure, and dysfunction following myocardial infarction.
Prinston Pharmaceutical, doing business as Solco Healthcare, is recalling "all lots" of Valsartan tablets manufactured by Zhejiang Huahai Pharmaceutical. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing. FDA has come up with the new solution of avoiding the vulsartan till when the doctor doesnot provide the substitute of this medication.