N-Nitroso N-Methyl 4-amino butyric acid (NMBA)
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Uses
- generated during the manufacturing process of losartan
Adverse effects
- known animal carcinomgen & potential human carcinogen
Notes
- found in loartan-containing products.[1]
More general terms
References
- ↑ 1.0 1.1 FDA News Release. March 1, 2019 FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632425.htm
FDA Safety Alert. Feb 28, 2019 Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient (API). https://www.fda.gov/Safety/Recalls/ucm632395.htm