The recall is sparked by "the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals," the news release states.
The pills come in bottles and those under the recall have the following lot numbers and expiration dates:
Irbesartan tablets 300MG 90CT, NDC code 43547-376-09, Lot number 331B18009, Expiration date 02/2021.
Irbesartan/HCTZ 300MG/12.5MG 30CT tablets, NDC code 43547-331-03, lot number 327A18001, expiration date 03/2021.
Irbesartan Tablets/HCTZ 300MG/12.5MG 30 CT tablets, NDC code 43547-331-03, lot number 327A18002, expiration date 03/2021.
Irbesartan Tablets/HCTZ 300MG/12.5MG 90CT tablets, NDC code 43547-331-09, lot number 327B18008, expiration date 03/2021.
Irbesartan/HCTZ 300MG/12.5MG 90CT tablets, NDC code 43547-331-09, lot number 327B18009, expiration date 03/2021.
Irbesartan/HCTZ 150MG/12.5MG 30CT, NDC code 43547-330-03, lot number 325D18004, expiration date 03/2021.
Irbesartan/HCTZ 150MG/12.5MG 90CT tablets, NDC code 43547-330-09, lot number 325B18004, expiration date 03/2021.
Irbesartan/HCTZ 150MG/12.5MG 30CT tablets, NDC code 43547-330-03, lot number 325D18005, expiration date 03/2021.
The substance is N-nitrosodiethylamine, and the medications recalled were found to have above the acceptable daily intake levels released by the Food and Drug Administration. As The AJC previously reported, the impurity, typically found in certain foods, drinking water and air pollution, has been classified as a human carcinogen by the International Agency for Research on Cancer.
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, the release states.
The FDA said that patients who have experienced any issues with the recall medication to contact their doctor. Patients should also contact either their doctor or pharmacist for alternative treatments, but to continue using the medication until they get direction from medical experts because stopping it could be a higher risk to their health than N-nitrosodiethylamine, according to the FDA.
This recall is the latest in the past few months. Since July, the FDA has announced voluntary recalls from Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries and Mylan Pharmaceuticals.