Torrent Pharmaceuticals on Thursday recalled an additional 104 lots of blood pressure medication: 36 lots of losartan potassium tablets and 68 lots of losartan potassium/hydrochlorothiazide tablets, the U.S. Food and Drug Administration announced on its website.
The recall was sparked by the “detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.”
The impurity detected is N-Methylnitrosobutyric acid (NMBA). Torrent is recalling only lots of losartan-containing products that contain NMBA 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 belong to a class of medicines used for treating high blood pressure called angiotensin II receptor blockers. Some generic versions of other ARBs, such as valsartan and irbesartan, have also been recalled.
Since July, the FDA has announced voluntary recalls of blood pressure and heart medications from Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries, Mylan Pharmaceuticals, Prinston Pharmaceuticals, Macleods Pharmaceuticals Limited, Camber Pharmaceuticals and Torrent.
To alleviate shortages caused by these recalls, the FDA last month approved a generic form of the blood pressure medication Diovan, or valsartan.
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 a.m. to 5 p.m. EST, voicemail available 24 hours a day, 7 days a week).
- Medinfo.Torrent@apcerls.com
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