Sunday, February 23, 2020

Sunday, February 23, 2020

Torrent's recall of drug to treat hypertension expanded

The recall of medications manufactured by Torrent Pharmaceuticals Ltd. to treat high blood pressure conditions has been expanded, the U.S. Food and Drug Administration reported.

Additional batches of losartan potassium tablets and losartan potassium/hydrochlorothiazide were found to contain excessive levels of an impurity, N-Methylnitrosobutyric acid (NMBA), according to a company announcement. NMBA is a substance identified by the International Agency for Research on Cancer as a likely carcinogen in humans.

The levels of NMBA detected in five additional lots of the medications were above the daily acceptable limit set by the FDA, Torrent reported.

Losartan potassium tablets are used to treat high blood pressure and are given to those with hypertension who have left ventricular hypertrophy, according to the company. In addition, the drug is used to help type-2 diabetes patients cope with nephropathy, a kidney disease.

Losartan potassium and hydrochlorothiazide pills are also designed to treat patients with high blood pressure and hypertensive people with left ventricular hypertrophy.

Those taking the medications should continue taking them, since the health risk to the patient may be higher than if the treatment is halted without an alternative drug, Torrent said in its announcement. Patients should consult their doctor or pharmacist about finding an alternative to the recalled medications, according to the company.


Lots Included in Latest Recall

National Drug CodeProduct Name, Strength and Package CountBatch NumberExpiration Date
13668-409-10Losartan Potassium Tablets, USP 50mg, 1,000 count4DU2E00912/31/2020
13668-115-90Losartan Potassium Tablets, USP 100mg, 90 count4DU3E00912/31/2020
13668-115-10Losartan Potassium Tablets, USP 100mg, 1,000 count4DU3E01802/28/2021
13668-116-90Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D05111/30/2020
13668-118-90Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count.4P04D00707/31/2020
Source: U.S. Food and Drug Administration

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U.S. Food and Drug Administration (FDA)

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