Just two weeks after recalling two lots of its version of Losartan Potassium USP tablets that have NDEA, Torrent Pharmaceuticals expanded the recall to 10 lots.
Several companies have yanked Losartan or Valsartan during the past six months over the presence of NDEA, considered a “probable human carcinogen” by the International Agency for Research on Cancer.
The company-written, FDA-posted recall notice clarified, “Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.”
Torrent’s Losartan is used to treat high blood pressure, heart problems and kidney problems related to Type 2 diabetes
As with the other Losartan/Valsartan recalls, Torrent advises patients against going off the drug without having in place an alternate treatment course established by a doctor or pharmacist.
December’s original recall covered lot Nos. BO31C016 and 4DK3C005 of Losartan Potassium USP tablets. This expansion adds:
100mg, 1,000-count bottles, lot Nos. 4DK3C004, 4DU3C040, 4DU3E049 and 4DU3E050.
50mg, 30-count bottles, lot No. 4L67C305.
50mg, 90-count bottles, lot Nos. 4L67C305 and 4L67C306.
50mg, 1,000-count bottles, lot No. 4O50C005.
25mg, 90-count bottles, lot No. 4O49C013.
Anyone with questions about the recall can call 800-912-9561 any time, although you’ll reach a person only from 8 a.m. to 5 p.m., Eastern time or email MedInfo.Torrent@apcerls.com. Anyone with questions about returning the drugs can call Qualanex at 1-888-280-2040 at any time, but will speak to a live person from 8 a.m. to 9 p.m., Eastern time.