FDA warns compounders not to use glutathione from Letco Medical to compound sterile drugs
Agency is aware of adverse events related to compounded glutathione injection [2/1/2019] FDA is warning compound ers not to use glutathione -L-reduced powder distributed by Letco Medical, Decatur, Alabama, to compound sterile injectable drugs for patients. Based on reported adverse events, the agency has concerns with use of the Letco distributed glutathione to compound injectable drugs due to potential endotoxins. Letco supplied this glutathione powder to about 100 compounders in 30 states. FDA urges compounders that use glutathione to make sterile injectable drugs to ensure the glutathione powder is appropriate for compounding sterile drugs, including checking with their supplier. FDA is aware of seven patients who experienced various adverse events ranging from nausea and vomiting to difficulty breathing,...