Recall Expanded for Losartan Potassium Tablets

JANUARY 04, 2019
For the latest recall information as of March 12, 2019 check here: FDA Officials OK New Generic Valsartan


A recall of Torrent Pharmaceuticals Limiteds Losartan Potassium Tablets USP has been expanded to include 8 additional lots. A total of 10 lots are now being recalled at the consumer level, including 2 recalled lots initially announced December 20, 2018.

Torrent's products are being recalled due to the detection of trace amounts of N-nitrosodiethylamine (NDEA), an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Since July, multiple companies have voluntarily recalled products containing valsartan, irbesartan, and losartan, stemming from concerns about NDEA levels. Earlier this week, Aurobindo Pharma USA announced it was voluntarily recalling 80 lots of valsartan tablets

NDEA is a substance that 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 classification. Torrent is only recalling lots of losartan-containing products that contain NDEA above the acceptable daily intake levels released by the FDA.

Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Patients who are taking Losartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment, according to the FDA. Patients also should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

In announcing the expanded recall, the FDA said Torrent Pharmaceuticals Limited has not received any reports of adverse events related to the recalled products. Consumers experiencing any problems that may be related to taking or using the recalled drug product should contact their physician or healthcare provider.

Losartan Potassium Tablets, USP were distributed nationwide, according to the FDA. A full list of products subject to this recall is available on the FDA’s website. Recalled items can be identified by checking the product name, manufacturer details, and batch or lot number on the bottle containing these products.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at:
  • 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).


Reference

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP [Company Announcement]. Silver Spring, MD; January 3, 2019: FDA website. http://www.pharmacytimes.com/link/242?rel=0" . Accessed January 4, 2019.

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