Global Scare Over Nitrosamine Impurities Extends To Diabetes Medication
Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.
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Why US FDA Requested Ranitidine Withdrawal, And How Other Drugs Could Follow
FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.
Why The US FDA Requested Ranitidine Withdrawal; How Other Withdrawals Could Follow
Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.
Pharmacy Calls For The FDA To Require Independent Third-Party Testing
An online pharmacy that tests medications before dispensing them advocated for regulations requiring independent testing and verification of the chemical content of pharmaceuticals; it also alleged that the US FDA’s testing method for evaluating the carcinogenic risk of metformin needs refinement.