01.02.2019

Heart And Blood Pressure Medication Recalled Because Of Impurity Found In Active Ingredient

The attorneys at Powell Law like to remain vigilant for products that may be dangerous to consumers. If you have any questions about litigating a claim for damages caused by a defective product, contact Powell Law. Our decades of experience make it the clear and obvious choice to meet all your legal needs, especially for representation in personal injury and products liability matters in the Scranton/Wilkes-Barre area.

In the first week of December 2018, two pharmaceutical companies recalled lots of Valsartan-containing products. Valsartan is used for the treatment of high blood pressure for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction. Valsartan in combination with amlodipine or hydrochlorothiazide is used for the treatment of high blood pressure.

Mylan Pharmaceuticals (Mylan) and Teve Pharmaceuticals (Teve) both issued recalls at the end of November while Mylan issued another related recall on December 4th of 2018. Both companies’ recalls are based on an impurity found in an active pharmaceutical ingredient (API) manufactured by Mylan known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. NDEA is typically found in minuscule amounts in certain foods, drinking water, air pollution, and certain industrial processes.

Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Mylan has directed customers to contact their physician or healthcare provider if they have experienced any problems that may be related to the use of these products. Mylan also directs that any adverse reactions be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Teve has directed its distributors and retailers to immediately stop distribution and quarantine any quantities remaining in their control and return the recalled product. The company is notifying its distributors and customers by certified mail and is arranging for the return of returned recalled products. Adverse reactions or other problems experienced with the use of Teva’s products may also be reported to Teva directly at 888-838-2872 or to the FDA’s MedWatch Adverse Event Reporting program.

Patients should contact their pharmacist or physician who may advise them about alternative treatments. Patients who have been prescribed and are taking valsartan should continue doing so, since any risk of harm to the patient’s health may be increased if the treatment is stopped immediately with no alternative.

If you or a loved one has suffered any type of injury resulting from the use of a product, contact Powell Law at (570) 961-0777. Our decades of experience make us the clear and obvious choice for all types of legal representation in the Scranton/Wilkes-Barre and surrounding areas. The consultation is FREE and you don’t pay anything unless we win. Our attorneys, past and present, have represented motor vehicle accident victims for 112 years. Call today!

 

Heart And Blood Pressure Medication Recalled Because Of Impurity Found In Active Ingredient

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