Add Yahoo as a preferred source to see more of our stories on Google. Hollis Johnson/Business Insider Nitrosamines are classified as potential cancer-causing agents. The chemicals have been found in ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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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 ...

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 ...