FDA issued a safety communication following adverse events associated with compounded IV glutathione made with dietary supplement-grade glutathione. FDA reports that some patients required hospitalization and that two pharmacies have recalled affected preparations.
The takeaway for compounders is simple: verify that every API and excipient is appropriate for its intended route of administration. Carefully review labels, COAs, supplier qualifications, and the source and quality of materials before using them in compounded preparations.
Read FDA’s safety communication.