Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

For Immediate Release

December 20, 2018

Contact

Consumers

Medinfo.Torrent@apcerls.com
1-800-912-9561

 

Announcement

Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which 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 (IARC) classification.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

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 on 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.

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. <

NDCManufacturerProduct DescriptionLot/BatchExpiration Date
13668-
115-30
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 100mg,30count bottlesBO31C01604/2019
13668-
115-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 100mg,90count bottlesBO31C01604/2019
13668-
115-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP
100mg,1000-count bottles
4DK3C00504/2019

Losartan potassium tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers. Torrent Pharmaceuticals Limited is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

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).

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product should be directed to Qualanex at 1-888-280-2040 (live calls received 8 am - 9:00 pm Eastern Time).

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Link to Expanded Recall

 

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Product Photos

“Product Image of Losartan Potassium Tablet, USP”

“Product Labeling of Losartan Potassium Tablet, USP 100 mg, 30 tablets”

“Product Labeling of Losartan Potassium Tablet, USP 100 mg, 90 tablets”

“Product Labeling of Losartan Potassium Tablet, USP 100 mg, 1000 tablets”

Page Last Updated: 01/03/2019
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