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By Erin Smith

A nationwide recall has been issued for  Irbesartan and Irbesartan HCTZ tablets due to possible contamination by cancer-causing agents. The recall  was issued by Prinston Pharmaceutical Inc., dba Solco Healthcare, LLC who manufactures the drug.

The lots involved in the recall contain an ingredient called N -nitrosodiethylamine (NDEA) which was found to be higher than the acceptable safe limits in some varieties. According to the pharmaceutical company, the substance occurs naturally in certain foods, drinking water, air pollution and industrial processes but has been found to be a possible cancer causing agent in humans at high levels.

ProductNDC CodeLot NumberExpiry DatesDistribution Date
IRBESARTAN TABLETS 300MG 90CT43547-376-09331B1800902/20218/9/2018
IRBESARTAN/HCTZ
300MG/12.5MG 30CT TABLETS
43547-331-03327A1800103/20217/10/2018
IRBESARTAN/HCTZ
300MG/12.5MG 30 CT TABLETS
43547-331-03327A1800203/20217/10/2018
IRBESARTAN/HCTZ 300MG/12.5MG 90CT
TABLETS
43547-331-09327B1800803/20217/10/2018
IRBESARTAN/HCTZ 300MG/12.5MG 90CT
TABLETS
43547-331-09327B1800903/20217/10/2018
IRBESARTAN/HCTZ 150MG/12.5MG 30CT43547-330-03325D1800403/20217/10/2018
IRBESARTAN/HCTZ
150MG/12.5MG 90CT TABLETS
43547-330-09325B1800403/20218/24/2018
IRBESARTAN/HCTZ 150MG/12.5MG 30CT
TABLETS
43547-330-03325D1800503/20217/10/2018

Customers and wholesalers are being notified by telephone and in writing by Prinston Pharmaceutical, Inc. with instructions on how to return their unused product. Retail outlets that have any of the products on their shelf should contact Prinston Pharmaceutical, Inc. for instructions on how to return the unused product.

Consumers who have products involved in the recall should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

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