One lot of Irbesartan and seven lots of Irbesartan HCTZ tablets, medications used to control high blood pressure and heart failure, containing a trace amount of an unexpected impurity N-nitrosodiethylamine (NDEA) at an unacceptable level, were voluntary recalled by Prinston Pharmaceutical Inc.
NDEA is classified as a probable human carcinogen as per the International Agency for Research on Cancer (IARC) classification. The ingredients were manufactured by Zheijiang Huahai Pharmaceuticals in China, a company which has been linked to several recalls of regularly-prescribed blood pressure drugs since July. Any reports of adverse events related to this recal are known. Prinston's Irbesartan and Irbesartan HCTZ were reportedly distributed nationnwide by Solco Healthcare to wholesale, distributor, repackager, and retail customers. Distributors and customers are being contacted immediately to discontinue distribution of the specific lots being recalled and to notify their sub accounts. The lots recalled are: