On June 11, the FDA announced recall expansion of Teva losartan potassium tablets, indicating the presence of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
Teva initially recalled 35 lots (six lots of 25 mg strength and 29 lots of 100 mg strength) of bulk Losartan Potassium tablets due to NMBA contamination in April this year. Following the expansion announcement, it is now recalling at least six more bulk lots, two of 50 mg strength and four of 100 mg strength generic losartan tablets, from hospitals and pharmacy shelves.
NMBA is the third chemical impurity which is found largely in generic blood pressure drugs. The acceptable exposure limit for the levels of NMBA is 9.82 parts per million (ppm). Research shows nitrosamines are linked to gastrointestinal tract cancers, including colon cancer, stomach cancer, and esophageal cancer. Also, nitrosamines may cause liver cancer, kidney cancer, and pancreatic cancer. There are 50 valsartan lawsuits pending in the federal litigation underway in New Jersey. The proceeding involves over 40 valsartan recall defendants, including Zhejiang Huahai, Teva Pharmaceutical Industries Ltd., Mylan NV, and CVS Health Co.
