In recent years, a number of drug companies have carried out prominent recalls of hypertension, heartburn and diabetes medications due to the presence of nitrosamines, organic compounds shown to cause cancer in animal studies. The problem could cost Big Pharma companies billions of dollars, but proving the cancer-causing role of nitrosamines in drugs may be difficult.…

The presence of toxic nitrosamine impurities in drug substances and drug products has become a significant focus for the pharmaceutical industry following their identification above permitted limits in common drug products prescribed for type 2 diabetes, high blood pressure and heartburn. To learn more about the situation, we interviewed David Elder – CMC consultant –…

Pfizer (NYSE:PFE) has announced a voluntary recall of five lots of Accupril (Quinapril HCl) tablets owing to elevated levels of the nitrosamine N-nitroso-quinapril.  Accupril, an angiotensin-converting enzyme (ACE) inhibitor, is indicated for treating hypertension. FDA has also approved its use as an adjunctive therapy for treating heart failure.  N-nitroso-quinapril, which can be frequently found in…