Loading…
Dextrum Laboratories Inc., an OTC drug manufacturer in Miami, failed to conduct required identity testing on incoming components used in cough and cold products, including dextromethorphan and glycerin, in violation of Current Good Manufacturing Practice regulations. The firm particularly failed to adequately test shipments of high-risk components susceptible to diethylene glycol or ethylene glycol contamination, rendering their drug products adulterated. These deficiencies were identified during an FDA inspection in July 2023 and documented in a warning letter issued in December 2023.