News | Pharmaceuticals | January 10, 2019

Aurobindo Pharma Adds to Nationwide Valsartan Blood Pressure Medication Recall

Recall initiated due to trace amounts of an impurity classified as a probable human carcinogen

Aurobindo Pharma Adds to Nationwide Valsartan Blood Pressure Medication Recall

January 10, 2019 — Aurobindo Pharma USA Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA Inc. has not received any reports of adverse events related to this recall.

The affected medications are indicated to control high blood pressure and for the treatment of heart failure. Patients who were prescribed Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The products subject to recall are listed on the U.S. Food and Drug Administration (FDA) website here. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

The affected medications were distributed nationwide to Aurobindo Pharma USA Inc. wholesale, distributor, repackager and retail customers. Aurobindo Pharma USA Inc. is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. The company is arranging for return of all recalled products to Inmar/CLS Medturn. Instructions for returning recalled products are given in the recall letter.

Mylan Pharmaceuticals announced a recall of all lots of its products containing Valsartan in December. The affected products in that recall were manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Ltd., and distributed in the U.S. between March 2017 and November 2018.

For more information: www.fda.gov

Related Content

Hypertension With Progressive Cerebral Small Vessel Disease Increases Cognitive Impairment Risk
News | Hypertension | January 08, 2019
Patients with high blood pressure and progression of periventricular white matter hyperintensities showed signs of...
Barbershop Intervention Continues to Lower Blood Pressure at One Year
News | Hypertension | December 27, 2018
African-American men participating in a blood pressure reduction program implemented in barbershops continued to have...
Analytics 4 Life and Actelion to Develop New Diagnostics for Pulmonary Hypertension
News | Hypertension | December 14, 2018
Digital health company Analytics 4 Life and Actelion Pharmaceuticals Ltd. announced a collaborative agreement to...
Hypertensive Crisis Five Times More Likely Among Blacks, according to a late-breaking study at AHA 2018. #AHA #AHA18 #AHA2018
News | Hypertension | November 13, 2018
Black adults experience dangerous spikes in high blood pressure, called a hypertensive crisis, at a rate that is five...
Home Monitoring Confirms Clinic Diagnosis of High Blood Pressure
News | Hypertension | October 29, 2018
Blood pressure readings of 130/80 millimeters of mercury (mmHg) or higher taken at home can be used to diagnose...
 Pulmonary artery denervation for CpcPH from the PADN-5 trial. #TCT2017

A series of procedural images of a pulmonary artery denervation for CpcPH from the PADN-5 trial.

News | Hypertension | October 04, 2018
October 4, 2018 — Pulmonary artery denervation (PADN) is associated with significant improvements in hemodynamic and
BackBeat Cardiac Neuromodulation Therapy Reduces Blood Pressure at Two Years
News | Hypertension | October 02, 2018
Two-year results of the Moderato I Study demonstrated immediate, substantial and sustained reduction in blood pressure...
Most Black Adults Have High Blood Pressure Before Age 55
News | Hypertension | July 30, 2018
July 30, 2018 — Approximately 75 percent of black and men women are...
American Heart Association Announces New Hypertension Center Certification
News | Hypertension | July 05, 2018
Physician practices now have access to new resources to improve their standard of quality care for hypertension...
Overlay Init