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FDA: Torrent Pharmaceuticals Limited recalls Losartan tablets

Posted at 5:16 AM, Mar 05, 2019
and last updated 2019-03-05 06:57:48-05

Torrent Pharmaceuticals Limited is recalling 60 lots of Losartan potassium tablets and 54 lots of Losartan potassium/ hydrochlorothiazide tablets because they contain "N-Methylnitrosobutyric (NMBA) acid above the acceptable daily intake levels released by the FDA," according to the U.S. Food and Drug Administration website.

The tablets treat hypertension and hypertensive patients with Left Ventricular Hypertrophy and nephropathy in Type 2 diabetic patients.

For a full list of the tablets affected by the recall, click here.

Patients "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."

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).
  • Medinfo.Torrent@apcerls.com

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).

To read the full release, click here.