Prinston Pharmaceutical Inc., dba Solco Healthcare LLC, has recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ blood pressure tablets. The medication may have trace amounts of an impurity known as N-nitrosodiethylamine (NDEA), which could cause cancer.

NDEA was detected in the recalled medication above the intake levels allowed by the U.S. Food and Drug Administration (FDA). NDEA has been classified as a possible carcinogen and is found in certain foods, drinking water, air pollution, and industrial processes.

The recalled Irbesartan and Irbesartan HCTZ tablets are used to control high blood pressure and for the treatment of heart failure. They are packaged in bottles and can be identified by checking the product name, manufacturer details, and batch or lot number on the bottle. A full list of the recalled medications can be found here.

The recalled medication was distributed nationwide. It was manufactured by Zhejiang Huahai Pharmaceuticals. The company has not received any adverse reports from the recalled blood pressure medication.

Patients taking the recalled medication should contact their pharmacist or physician to receive an alternate form of treatment. Patients using Irbesartan should continue taking their medication until they are provided a replacement or different medication type for their condition. They should not stop the blood pressure medication without alternative treatment as this could pose a greater risk of harm.

Consumers that experience problems with the recalled medication should contact their physician or healthcare provider.

To return the product, it can be mailed to Eversana, Attn: Returns Department C/O Solco Healthcare 4580 S. Mendenhall, Memphis, TN 38141. A return label will also be provided free of charge from the company by contacting customer service via email at customerservice@solcohealthcare.com or by fax at 1-866-931-0709.

Adverse reaction or quality issues can be reported to the U.S. Food and Drug Administration’s MedWatch Adverse Event Reporting program by phone, online, fax or by mail. Forms can be completed and submitted online at www.fda.gov/medwatch/report.htm. To mail or fax a form, it can be downloaded at www.fda.gov/MedWatch/getforms.htm. Forms can also be obtained by calling 1-800-332-1088. Fax number is 1-800-FDA-0178.

The recall has been made in conjunction with the FDA.