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
Akorn Inc
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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