FDA-Drug2017-08-23Class III
Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014
Hazard
Crystallization with subpotent out of specification assay results for chlorhexidine.
Sold states
Nationwide in the USA
Affected count
101,952 15 mL unit dose cups
Manufactured in
1925 W Field Ct, N/A, Lake Forest, IL, United States
Products
Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1090-2017Don't want to check this manually?
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