Akorn Inc recalls Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (
Recalled August 23, 2017 · FDA recall D-1088-2017 · Akorn
Hazard
Crystallization with subpotent out of specification assay results for chlorhexidine. · FDA Class III
Units
541,900 unit dose cups (5,419 trays)
Sold at
Nationwide in the USA
Description
Crystallization with subpotent out of specification assay results for chlorhexidine.
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.
Manufacturer(s)
Akorn Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →