Home Health News High blood pressure tablets recalled due to trace of possible cancer-causing substance – WZTV

High blood pressure tablets recalled due to trace of possible cancer-causing substance – WZTV

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A voluntary recall has been issued for one lot of Irbesartan and seven lots of Irbesartan HCTZ tablets due to the detection of a trace amount of an unexpected impurity in the medicine.

Prinston recalled lots of Irbesartan products that contained N- nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA. N-nitrosodiethylamine (NDEA) is a substance that has been classified as a probable human carcinogen by the International Agency for Research on Cancer.

Irbesartan and Irbesartan HCTZ are used to control high blood pressure and treat heart failure. The tablets were distributed nationwide to wholesale, distributor, repackager and retail customers.

The pharmaceutical company has not received any reports of adverse events from the recall at this time, according to the FDA.

The products subject to the recall are listed below:

Product: IRBESARTAN TABLETS 300MG 90CT

NDC Code: 43547-376-09

Lot Number: 331B18009

Expir. Dates: 02/2021

Distribution Dates: 8/9/2018

Product: IRBESARTAN/HCTZ

300MG/12.5MG 30CT TABLETS

NDC Code: 43547-331-03

Lot Number: 327A18001

Expir. 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

Expir. Dates: 03/2021

Distribution Dates: 7/10/2018

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

TABLETS

NDC Code: 43547-331-09

Lot Number: 327B18008

Expir. Dates: 03/2021

Distribution Dates: 7/10/2018

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

TABLETS

NDC Code: 43547-331-09

Lot Number: 327B18009

Expir. Dates: 03/2021

Distribution Dates: 7/10/2018

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

NDC Code: 43547-330-03

Lot Number: 325D18004

Expir. Dates: 03/2021

Distribution Dates: 7/10/2018

Product: IRBESARTAN/HCTZ

150MG/12.5MG 90CT TABLETS

NDC Code: 43547-330-09

Lot Number: 325B18004

Expir. Dates: 03/2021

Distribution Dates: 8/24/2018

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

TABLETS

NDC Code: 43547-330-03

Lot Number: 325D18005

Expir. Dates: 03/2021

Distribution Dates: 7/10/2018

Impacted products at pharmacies should be returned using the following instructions:

– Immediately examine your inventory and quarantine product subject to recall.

– Immediately discontinue use and distribution of the identified lot numbers. A credit memo will be issued covering the quantity of your product returned.

Return products to:

Eversana

Attn: Returns Department C/O Solco Healthcare 4580 S. Mendenhall,

Memphis, TN 38141

More information about the recall can be found here.

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