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You are here: Home / Food Recalls / FDA Press Releases / UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

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

January 22, 2019 By The FDA Leave a Comment

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.

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
13668-
116-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM and
HYDROCHOLOROTHIAZIDE TABLETS, USP
50mg/12.5 mg, 90 count bottles.
BP02C008 03/2019
13668-
116-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM and
HYDROCHOLOROTHIAZIDE TABLETS, USP
50mg/12.5 mg, 1000 count bottles.
BEF7D006 03/2020
13668-
117-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM and
HYDROCHOLOROTHIAZIDE TABLETS, USP
100 mg/12.5 mg, 90 count bottles.
BX35C020 05/2019
13668-
117-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM and
HYDROCHOLOROTHIAZIDE TABLETS, USP
100 mg/12.5 mg, 90 count bottles.
BX35C049 08/2019
13668-
117-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM and
HYDROCHOLOROTHIAZIDE TABLETS, USP
100 mg/12.5 mg, 1000 count bottles.
BX35C022 05/2019
13668-
117-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM and
HYDROCHOLOROTHIAZIDE TABLETS, USP
100 mg/12.5 mg, 1000 count bottles.
BX35C023 05/2019

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

###

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Filed Under: FDA Press Releases

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