Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one lot of irbesartan and seven lots of irbesartan HCTZ tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.

Prinston is only recalling lots of irbesartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the US Food and Drug Administration (FDA).

NDEA 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, Prinston Pharmaceutical Inc. has not received any reports of adverse events related to this recall.

Irbesartan and irbesartan HCTZ are used to control high blood pressure and for the treatment of heart failure. Irbesartan in combination with amlodipine plus hydrochlorothiazide is used to control high blood pressure.

Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on irbesartan should continue taking their medication until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.

The products subject to recall are listed here and packaged in bottles. The product can be identified by checking the product name, manufacturer details, and batch or lot number on the bottle containing these products.