FDA Issues Voluntary Recall of Blood Pressure Medication Due to Cancer Concerns

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By : Suvarna Sheth

A voluntary recall of a blood pressure medication due to impurities, which may lead to a cancer risk, was recently issued by Sandoz Inc.

The company is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg.

The recall extends to the consumer level.

According to an FDA, the product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA).

The impurity, according to an FDA statement, occurs naturally in certain foods, drinking water, air pollution, and industrial processes and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

Losartan Potassium Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

The product can be identified as Losartan Potassium Hydrochlorothiazide, 100 mg/25 mg tablets in 1000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020.

This product was distributed nationwide to distributors. The affected product was not distributed prior to October 8, 2018.

To date, Sandoz Inc. has not received any reports of adverse events related to this lot.

For more information, see the FDA recall notice.

 

Sources:

  1. Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API). 2018, November 8, 2018. Retrieved: https://www.fda.gov/Safety/Recalls/ucm625492.htm

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