Nitrosamines are classified as potential cancer-causing agents. The chemicals have been found in several prescription drugs in recent years, prompting recalls. Most recently, Pfizer issued a voluntary ...

Ascend Laboratories, maker of generic dabigatran etexilate, is recalling 10 manufacturing lots of the oral anticoagulant because of an unacceptably high level of a possible carcinogen, according to a ...

Hospitals should start conserving supply of short-term anesthetics as drug manufacturers become more conservative with nitrosamine measures, according to Eric Tichy, PharmD. In 2021, the FDA issued a ...

Nitrosamine impurities became a topic of focus when health regulators recalled valsartan, an antihypertensive drug, due to the presence of N-nitrosodimethylamine (NDMA), a probable carcinogenic agent ...

As federal regulators increase their focus on pharmaceuticals with unacceptable levels of the probable carcinogen nitrosamine, a McHenry County drug delivery company is working on packaging that would ...

In 2018, a nitrosamine impurity (N-nitrosodimethylamine or “NDMA”) was detected in several pharmaceutical drugs containing the active ingredient valsartan, which resulted in a voluntary product recall ...

Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and ...

On September 1, 2020, the U.S. Food and Drug Administration (“FDA”) released a new guidance document, Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs,[i] following a series of ...

Detection of nitrosamines in several commercial drugs has resulted in manufacturing batch recalls followed by a review of the APIs’ synthesis processes by MAHs. Detection and quantitation of ...

The FDA has designated this a Class II recall. Over 7100 bottles of duloxetine have been recalled due to the presence of a nitrosamine impurity, N-nitroso-duloxetine, according to the Food and Drug ...