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Torrent Pharmaceuticals announced that it has expanded its voluntary recall of blood pressure medications after testing revealed trace amounts of a known probable human carcinogen.
The company added five lots of the generic drug losartan (three lots of losartan potassium tablets and two lots of losartan potassium/hydrochlorothiazide tablets) to an April recall of more than 100 lots of the same medications. The lots similarly were found to contain N-methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the U.S. Food and Drug Administration (FDA).
Patients currently taking the medication should continue doing so “as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician, who can advise them about an alternative treatment prior to returning their medication,” the company said in a statement posted on the FDA website.
The FDA began testing all heart drugs called angiotensin II receptor blockers for impurities after July 2018, when traces of the carcinogen N-nitrosodimethylamine (NDMA) were found in blood pressure medications from different companies that contained valsartan from a Chinese supplier.
The newly recalled products can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products. The lots include:
- Losartan Potassium Tablets, USP 50mg, 1,000 count (National Drug Code 13668-409-10; Batch Number 4DU2E009; Expiration Date 12/31/2020)
- Losartan Potassium Tablets, USP 100mg, 90 count (National Drug Code 13668-115-90; Batch Number 4DU3E009; Expiration Date 12/31/2020)
- Losartan Potassium Tablets, USP 100mg, 1,000 count (National Drug Code 13668-115-10; Batch Number 4DU3E018; Expiration Date 02/28/2021)
- Losartan Potassium/Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count (National Drug Code 13668-116-90; Batch Number BEF7D051; Expiration Date 11/30/2020)
- Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count (National Drug Code 13668-118-90; Batch Number 4P04D007; Expiration Date 07/31/2020)