The Food and Drug Administration has announced the recall of some blood pressure medicine over concerns that some of the product may be contaminated with a carcinogen linked to cancer.
Aurobindo Pharma USA, Inc. is recalling 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP.
The company says it has detected trace amounts of N-nitrosodiethylamine, which has been classified as a probable human carcinogen by the International Agency for Research on Cancer.
To date, Aurobindo Pharma says it has not received any reports of adverse events related to the recall.
Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP are used to control high blood pressure and for the treatment of heart failure.
According to the company, patients are being advised to 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 below and packaged in bottles. They can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
The 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.
Instructions for returning recalled products are given in the recall letter.
Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:
1-866-850-2876 Option 2
Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the drug.
Any general questions regarding the return of this product please contact Inmar\CLS-Medturn at 1-877-208-2407 or email firstname.lastname@example.org (live calls received 9 am -5:00 pm Eastern Time).
Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, online, by regular mail or by fax.