FDA Finalizes Guidelines To Keep Cancerous Impurities Out of U.S. Medications
Nitrosamine contamination has resulted in massive recalls for valsartan, Zantac and other medications, as well as lawsuits by users who developed cancer.
Nitrosamine contamination has resulted in massive recalls for valsartan, Zantac and other medications, as well as lawsuits by users who developed cancer.
The Defense Department is reportedly seeking Valisure's help in ensuring generic drugs, often manufactured overseas and away from FDA influence, given to military service members are safe and effective
Merck indicates it has identified the cause of nitrosamine contaminants in some batches of Januvia and Janumet, which occurs during the manufacturing and storage process.
Inspectors say Valisure appeared to be unfamiliar with key portions of the Food, Drug and Cosmetic Act linked to drug supply chain security.