Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines .
The products subject to recall are packed in bottles. These lots were distributed Nationwide to Teva’s Direct Accounts (Wholesale/Distributor/Retail/Repackagers/VA Pharmacy, et. al).
These were distributed under the Actavis label in the U.S. They are being recalled due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) that was manufactured by Zhejiang Huahai Pharmaceutical.
Teva is not the only company to recall Valsartan. Major Pharmaceuticals, and Solco Healthcare are also recalling Valsartan/ Hydrochlorothiazide due to the same impurity detected.
The FDA action came after 22 other countries issued recalls involving 2,300 valsartan batches sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta.
What Is Valsartan?
Valsartan is used for the treatment of hypertension (high blood pressure) and for the treatment of heart failure. It is also indicated as a treatment for left ventricular failure and left ventricular dysfunction following myocardial infarction. In combination with hydrochlorothiazide, it is used in the treatment of hypertension.
Why Is It Being Recalled?
The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes. It can be used to make liquid rocket fuel, softeners and lubricants, among other products. 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.a
N- nitrosodimethylamine (NDMA) has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
The toxin affects the liver and causes liver fibrosis or scarring and liver tumors in rats.Exposure to high levels of NDMA may cause liver damage in humans, according to the US Environmental Protection Agency.
To date, TEVA has not received any reports of adverse events related to this recall.
What Should You Do?
Don’t stop taking your blood pressure meds!!
First of all, not all medicines containing valsartan are involved in the recall.
Check the FDA recall site or call your pharmacy to find out if the bottle you have is from a contaminated lot before taking further action.
Valsartan alternatives are available.
Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. 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.
Questions, concerns, adverse reactions or quality problems experienced with the use of this product may be reported to Teva directly at 888- 838-2872 or to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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