High blood pressure medication RECALLED due to possible cancer-causing substance

By | January 23, 2019

High blood pressure tablets Irbesartan HCTZ have been recalled nationwide in the US due to a possible cancer risk. Prinston Pharmaceutical Inc. recalled the products that contained N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the US Food and Drug Administration (FDA). NDEA is a substance found in tobacco smoke which has been classified as a carcinogen by the World Health Organization and the International Agency for Research on Cancer. Both Irbesartan and Irbesartan HCTZ are used to control high blood pressure and treat heart failure in the US and the UK.

Princeton has not received any reports of adverse events from the recall at this point in time, according to the FDA.

The products subject to the recall are:

Product: IRBESARTAN TABLETS 300MG 90CT

NDC Code: 43547-376-09

Lot Number: 331B18009

Expiry Dates: 02/2021

Distribution Dates: 8/9/2018

Product: IRBESARTAN/HCTZ 300MG/12.5MG 30CT TABLETS

NDC Code: 43547-331-03

Lot Number: 327A18001

Expiry Dates: 03/2021

Distribution Dates: 7/10/2018

Product: IRBESARTAN/HCTZ 300MG/12.5MG 30 CT TABLETS

NDC Code: 43547-331-03

Lot Number: 327A18002

Expiry Dates: 03/2021

Distribution Dates: 7/10/2018

Product: IRBESARTAN/HCTZ 300MG/12.5MG 90CT TABLETS

NDC Code: 43547-331-09

Lot Number: 327B18008

Expiry Dates: 03/2021

Distribution Dates: 7/10/2018

Product: IRBESARTAN/HCTZ 300MG/12.5MG 90CT TABLETS

NDC Code: 43547-331-09

Lot Number: 327B18009

Expiry Dates: 03/2021

Distribution Dates: 7/10/2018

Product: IRBESARTAN/HCTZ 150MG/12.5MG 30CT

NDC Code: 43547-330-03

Lot Number: 325D18004

Expiry Dates: 03/2021

Distribution Dates: 7/10/2018

Product: IRBESARTAN/HCTZ 150MG/12.5MG 90CT TABLETS

NDC Code: 43547-330-09

Lot Number: 325B18004

Expiry Dates: 03/2021

Distribution Dates: 8/24/2018

Product: IRBESARTAN/HCTZ 150MG/12.5MG 30CT TABLETS

NDC Code: 43547-330-03

Lot Number: 325D18005

Expiry Dates: 03/2021

Distribution Dates: 7/10/2018

Impacted products at pharmacies in the US should be returned, and use and distribution should be immediately discontinued.

Express.co.uk has contacted the Medicines and Healthcare products Regulatory Agency (MHRA) who say patients and pharmacies in the UK are not subject to the recall.

At the beginning of this month, the MHRA announced a recall of certain irbesartan containing products made by Actavis (now Accord) as a precautionary measure, due to possible N‑nitrosodiethylamine (NDEA) contamination.

It stated: “There is no evidence at present that the impurity has caused any harm to patients and not all irbesartan products are affected. People should not stop their medication and should speak to a doctor or pharmacist if they have any concerns.

“The recall follows a Europe-wide investigation into contamination of sartan products. MHRA twice recalled batches of valsartan to pharmacy level in 2018; valsartan containing medicines from Dexcel and Actavis (now Accord) were recalled in July and batches of valsartan containing medicines made by Mylan and Teva, were also recalled to pharmacy level in November.

“The first recall occurred after an impurity, N-nitrosodimethylamine (NDMA), was identified as part of the manufacturing process in a valsartan active substance manufactured at one facility based in China. A second impurity, NDEA, was later discovered.

“MHRA are working closely with other EU member states, the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM) to ensure a thorough investigation and we will consider the impact in the UK and what actions may be necessary.”

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