Drug recall update: Irbesartan and Irbesartan HCTZ

Date: 01/31/19

On January 18, 2019, the U.S. Food and Drug Administration (FDA) announced that Prinston Pharmaceuticals, Inc. was voluntarily recalling Irbesartan and Irbesartan HCTZ tablets to the consumer level. This recall has been initiated due to the presence of an impurity, NDEA. 

The FDA press release states the following:
Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) 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 FDA. N-nitrosodiethylamine (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.

If you have any questions or concerns about Envolve Pharmacy Solutions’ response to the product recall, please contact Nelson Aragon, PharmD, Drug Utilization Review Clinical Pharmacist, at 800-225-2573, ext. 809-3034 or e-mail at Nelson.Aragon@EnvolveHealth.com, or contact Taline Jaghasspanian, PharmD, Senior Manager, Clinical Pharmacy Operations, at 818-676-6959, or email at Taline.Jaghasspanian@EnvolveHealth.com.

Read the Full Announcement from the FDA