Six Additional Lots of Losartan Tablets Recalled

JANUARY 23, 2019
Torrent Pharmaceuticals Limited has expanded its voluntary recall of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP. The recall was issued due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The recall of Torrent's Losartan products was initially announced December 20, 2018, and was expanded on January 3, 2019. A total of 16 lots have been recalled, all at the consumer level.

The impurity detected in the API is N-nitrosodiethylamine (NDEA), a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen by the international Agency for Research on Cancer (IARC). Torrent is only recalling lots of losartan containing products that contain NDEA above the acceptable daily intake levels released by the FDA.

Since July, multiple companies have voluntarily recalled products containing valsartan, irbesartan, and losartan, stemming from concerns about NDEA levels. They include Aurobindo Pharma USA, which recently recalled 80 lots of valsartan tablets.

According to the FDA, on Tuesday, Torrent has not received any reports of adverse events related to the company's Losartan recall. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

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. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

Patients who are on losartan potassium and hydrocholothiazide tablets, USP 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.

The products subject to recall are packaged in bottles and listed on the FDA’s website. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products. 

Losartan potassium tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers. Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited by phone at 1-800-912-9561 and by email at  Medinfo.Torrent@apcerls.com.


Reference

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP [press release]. Silver Spring, MD; January 22, 2019: FDA website. http://www.pharmacytimes.com/link/247. Accessed January 23, 2019.


 

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