Irbesartan and Irbesartan HCTZ Tablets
Date of Recall: January 18, 2019
Recalling Firm(s): Prinston Pharmaceutical Inc.
Product: Irbesartan and Irbesartan HCTZ Tablets.
Scope of recall: Please click on the link below to see specific recalled catalog numbers and associated lot numbers.
Description: Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has voluntarily recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ Tablets due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected is N-nitrosodiethylamine (“NDEA”) — a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes. NDEA has been classified as a probable human carcinogen by the International Agency for Research on Cancer (“IARC”). To date, Prinston Pharmaceutical, Inc. has not received any reports of adverse events related to this recall.
Ibesartan and Ibesartan HCTZ are used to control high blood pressure and for the treatment of heart failure. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to stopping and returning their medication. Patients are advised to continue taking their medication until they are given a new medication from their pharmacist or their doctor has prescribed a new medication and/or treatment plan.
For more information, please see the safety announcement posted on the FDA website. https://www.fda.gov/Safety/Recalls/ucm629627.htm.