Trace amounts of an unexpected impurity, N-nitrosodiethylamine (NDEA), which has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
There have been no reports of adverse events.
The following products, used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients, are being recalled:
| NDC | Manufacturer | Product Description | Lot/Batch | Exp. |
|---|---|---|---|---|
| 13668- 115-30 | Torrent LTD | LOSARTAN POTASSIUM TAB, USP 100mg 30count bottles | BO31C016 | 04/2019 |
| 13668- 115-90 | Torrent LTD | LOSARTAN POTASSIUM TAB, USP 100mg 90count bottles | BO31C016 | 04/2019 |
| 13668- 115-10 | Torrent LTD | LOSARTAN POTASSIUM TAB, USP 1000-count bottles | 4DK3C005 | 04/2019 |
The recalled products were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers.
What to do
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.
Torrent Pharmaceuticals is notifying customers by phone and in writing, arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.
Consumers with medical questions or reporting an adverse event may contact Torrent at (800) 912-9561 8:00 am – 5:00 pm (ET), or by email at Medinfo.Torrent@apcerls.com
Questions regarding the return of the recalled product may be be directed to Qualanex at (888) 280-2040 from 8 am - 9:00 pm (ET).