Tag Archive for: contaminated medicine

The FDA issued complete response letters to Phathom Pharmaceuticals, flagging the presence of N-nitroso-vonoprazan (NVP) impurities detected in the company’s approved Helicobacter pylori drug products, the company announced Thursday.

The U.S. Food and Drug Administration has warned against using an India-made eye drop that has been linked to the outbreak of a drug-resistant bacteria leading to adverse events in at least 55 patients including infections, blindness and one death.

Last year more than 300 children – mainly aged under 5 – died of acute kidney injury, deaths that were associated with contaminated medicines, the WHO said in a statement.