FDA extends recall of popular antihypertensive drugs



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The Food and Drug Administration has once again broadened its recall of widely prescribed hypertension medications after discovering traces of a cancer-related chemical during testing.

The latest recall, announced Monday, targets five more batches of the losartan drug sold by Torrent Pharmaceuticals. The batches include losartan potassium tablets and losartan potassium / hydrochlorothiazide tablets.

The affected lots are listed below. Products can be identified by verifying the product name, manufacturer details, and lot or lot number on the bottle containing these products:

  • 13668-409-10 Losartan Potassium Tablets, USP 50 mg, 1000 units. Lot number: 4DU2E009. Expiration date: 31/12/2020
  • 13668-115-90 Losartan Potassium Tablets, USP 100 mg, 90 units. Lot number: 4DU3E009. Expiration date: 31/12/2020
  • 13668-115-10 Losartan Potassium Tablets, USP 100 mg, 1000 units. Lot number: 4DU3E018. Expiration Date: 28/02/2021
  • 13668-116-90 Potassium and hydrochlorothiazide tablets of losartanUSP 50 mg / 12.5 mg, 90 units. Lot number: BEF7D051. Expiration date: 30/11/2020
  • 13668-118-90 Potassium and hydrochlorothiazide tablets of losartan, USP 100 mg / 25 mg, 90 units. Lot number: 4P04D007. Expiration date: 31/07/2020

The FDA has stated that tests have detected levels of N-methylnitrosobutyric acid, or NDMA, a known carcinogen, greater than acceptable.

Losartan is a generic angiotensin II receptor blocker, or ARB, and it is used to treat high blood pressure, left heart-ventricle problems and nephropathy in patients with type 2 diabetes, among other conditions. Losartan potassium tablets and hydrochlorothiazide are also used to treat hypertension and heart problems

Over the last year, dozens of generic ARA lots have been pulled off the market due to the presence of various potential contaminants. The last reminder is the FDA's fifth expansion of the Torrent losartan.

Consumers who take the medicine should consult their physician to discuss the recall before stopping the medication or if they have any drug-related side effects.

Anyone with questions about the latest recall or to report an adverse event, even for the affected product, may call Torrent Pharmaceuticals at 1-800-912-9561 24 hours a day, seven days a week.

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