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 ...

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 ...

Nitrosamine drug substance-related impurities (NDSRIs) are structurally similar to APIs, posing higher risks and requiring advanced detection methods. The Carcinogenic Potency Categorization Approach ...

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 ...

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 ...

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 ...

Pfizer is recalling multiple blood pressure medications due to elevated levels of nitrosamine, which can increase the risk of cancer. The company said it is voluntarily recalling six lots of Accuretic ...