How FDA drug recalls work
Another 19 lots of losartan tablets, these made by Vivimed Life Sciences and distributed by Heritage Pharmaceuticals, have been recalled for exceeding the FDA allowable amount of NMBA.
“Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA (N-Nitroso-N-methyl-4-aminobutyric acid) cannot be ruled out,” said the company-written, FDA-posted recall notice.
This covers Losartan Potassium Tablets USP in strengths of 25mg, 50mg and 100mg in 90-count or 1,000-count bottles with these lot Nos.:
CLO17006A, CLO17007A, CLO17008A, CLO17009A, CLO17010A, CLO17012A, CLO17013A, CLO17014A, CLO17015A, CLO17016A, CLO17017A, CLO17009B, CLO18001A, CLO18002A, CLO18020A, CLO18021A, CLO18022A, CLO18023A and CLO18002B. The list of tablets in this recall with expiration dates can be found here.
The FDA has been reminding people who learn their losartan, valsartan or irbesartan has been recalled to not stop taking their medication until their doctor or medical professional sets up an alternate course of treatment.
Those with questions about this recall can contact Vivimed in care of Inmar at 1-877-861-3811 Monday through Friday, 9 a.m. to 5 p.m., Eastern time.