Torrent Pharmaceuticals Limited has issued a voluntary recall on two lots of Losartan potassium tablets, according to the United States Food and Drug Administration.
The purpose for the recall is trace amounts of an impurity were found in an active ingredient manufactured by Hetero Labs Limited. The detected impurity is N-nitrosodiethylamine (NDEA) which can occur naturally in drinking water, air pollution and industrial processes and is classified as a carcinogen in humans.
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.
| 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 |
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).
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