FDA-Drug2017-08-23Class III
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.
Akorn Inc
Hazard
Crystallization with subpotent out of specification assay results for chlorhexidine.
Sold states
Nationwide in the USA
Affected count
541,900 unit dose cups (5,419 trays)
Manufactured in
1925 W Field Ct, N/A, Lake Forest, IL, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1088-2017Don't want to check this manually?
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