Product: Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.
Reason for recall: Crystallization with subpotent out of  specification assay results for chlorhexidine.
Recall initiated: 20170712
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated