Specifically, 1 lot of Irbesartan tablets and 7 lots of Irbesartan HCTZ tablets are being recalled by Prinstin Pharmaceuticals, who said the drugs contained unacceptable levels of Nitrosodiethylamine (NDEA) a likely human carcinogen (cancer-causing substance).
The ingredients were manufactured by Zheijiang Huahai Pharmaceuticals, a Chinese company that has been linked to a number of recent recalls over prescription blood pressure meds.
Specific products affected by the latest recall include:
- IRBESARTAN TABLETS 300MG 90CT 43547-376-09 331B18009 02/2021 8/9/2018
- IRBESARTAN/HCTZ 300MG/12.5MG 30CT TABLETS 43547-331-03 327A18001 03/2021 7/10/2018
- IRBESARTAN/HCTZ 300MG/12.5MG 30 CT TABLETS 43547-331-03 327A18002 03/2021 7/10/2018
- IRBESARTAN/HCTZ 300MG/12.5MG 90CT TABLETS 43547-331-09 327B18008 03/2021 7/10/2018
- IRBESARTAN/HCTZ 300MG/12.5MG 90CT TABLETS 43547-331-09 327B18009 03/2021 7/10/2018
- IRBESARTAN/HCTZ 150MG/12.5MG 30CT 43547-330-03 325D18004 03/2021 7/10/2018
- IRBESARTAN/HCTZ 150MG/12.5MG 90CT TABLETS 43547-330-09 325B18004 03/2021 8/24/2018
- IRBESARTAN/HCTZ 150MG/12.5MG 30CT TABLETS
Source: ABC KGUN 9