FDA Drug Class III — Least Serious

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.

Hazard

Crystallization with subpotent out of specification assay results for chlorhexidine.

Products

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.
Brand
Akorn Inc
UPC
Lot: 353394, Exp 10-2018

Units Affected

541,900 unit dose cups (5,419 trays)