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Recall Expanded for Losartan Potassium Tablets

A recall of Torrent Pharmaceuticals Limited’s 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).

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

NDC Manufacturer Product Description Lot/Batch Expiration Date
13668-
115-30
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 100mg,30count bottles BO31C016 04/2019
13668-
115-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 100mg,90count bottles BO31C016 04/2019
13668-
115-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP
100mg,1000-count bottles
4DK3C005 04/2019
13668-
115-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP
100mg,1000-count bottles
4DK3C004 04/2019
13668-
115-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP
100mg,1000-count bottles
4DU3C040 10/2019
13668-
115-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP
100mg,1000-count bottles
4DU3E049 05/2021
13668-
115-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP
100mg,1000-count bottles
4DU3E050 05/2021
13668-
409-30
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 50mg,30count bottles 4L67C035 10/2019
13668-
409-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 50mg,90count bottles 4L67C035 10/2019
13668-
409-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 50mg,90count bottles 4L67C036 10/2019
13668-
409-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP
50mg,1000-count bottles
4O50C005 11/2019
13668-
113-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 25mg,90count bottles 4O49C013 09/2019
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