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.

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

For Immediate Release

January 22, 2019

Contact

Consumers

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

Announcement

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide 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. Torrent is only recalling lots of losartan containing products that contain Nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

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.

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 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
13668-
115-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP
100mg,1000-count bottles
4DK3C00404/2019
13668-
115-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP
100mg,1000-count bottles
4DU3C04010/2019
13668-
115-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP
100mg,1000-count bottles
4DU3E04905/2021
13668-
115-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP
100mg,1000-count bottles
4DU3E05005/2021
13668-
409-30
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 50mg,30count bottles4L67C03510/2019
13668-
409-90

 

Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 50mg,90count bottles4L67C03510/2019
13668-
409-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 50mg,90count bottles4L67C03610/2019
13668-
409-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP
50mg,1000-count bottles
4O50C00511/2019
13668-
113-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 25mg,90count bottles4O49C01309/2019
13668-
116-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM and
HYDROCHOLOROTHIAZIDE TABLETS, USP
50mg/12.5 mg, 90 count bottles.
BP02C00803/2019
13668-
116-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM and
HYDROCHOLOROTHIAZIDE TABLETS, USP
50mg/12.5 mg, 1000 count bottles.
BEF7D00603/2020
13668-
117-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM and
HYDROCHOLOROTHIAZIDE TABLETS, USP
100 mg/12.5 mg, 90 count bottles.
BX35C02005/2019
13668-
117-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM and
HYDROCHOLOROTHIAZIDE TABLETS, USP
100 mg/12.5 mg, 90 count bottles.
BX35C04908/2019
13668-
117-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM and
HYDROCHOLOROTHIAZIDE TABLETS, USP
100 mg/12.5 mg, 1000 count bottles.
BX35C02205/2019
13668-
117-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM and
HYDROCHOLOROTHIAZIDE TABLETS, USP
100 mg/12.5 mg, 1000 count bottles.
BX35C02305/2019

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 Original Recall

Link to Expanded Recall

 

###

Product Photos

“Product Image of Losartan Potassium Tablet 25 mg, USP”

“Product Image of Losartan Potassium Tablet 50 mg, USP”

“Product Image of Losartan Potassium Tablet 100 mg, USP”

“Product Labeling of Losartan Potassium Tablet, USP 25 mg, 90 tablets”

“Product Labeling of Losartan Potassium Tablet, USP 50 mg, 30 tablets”

“Product Labeling of Losartan Potassium Tablet, USP 50 mg, 90 tablets”

“Product Labeling of Losartan Potassium Tablet, USP 50 mg, 1000 tablets”

“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”

Image, losartan potassium and hydrochlorothiazide tablet 50 mg/12.5 mg

Image, losartan potassium and hydrochlorothiazide tablet 100 mg/12.5 mg

Label, losartan potassium and hydrochlorothiazide tablets 50 mg/12.5 mg, 1000 count

Label, losartan potassium and hydrochlorothiazide tablets 50 mg/12.5 mg, 90 count

Label, losartan potassium and hydrochlorothiazide tablets 100 mg/12.5 mg, 90 count

Label, losartan potassium and hydrochlorothiazide tablets 100 mg/12.5 mg, 1000 count

Page Last Updated: 01/24/2019
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