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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

As part of the ongoing safety investigation of potentially carcinogenic impurities detected in angiotensin II receptor blocker (ARB) medications, the Food and Drug Administration (FDA) has released a ...

The Food and Drug Administration (FDA) has outlined industry guidance for Control of Nitrosamine Impurities in Human Drugs (Rev 1-Feb2021) authorization holders (MAHs) on risk measures to tackle ...

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 ...

Recent tests of 13 lots of the skeletal muscle relaxant Orphenadrine Citrate 100 mg Extended Release (ER) found unacceptably high levels of a nitrosamine impurity in the tablets, leading manufacturer ...