Akorn Inc recalls Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufacture
Recalled August 23, 2017 · FDA recall D-1090-2017 · Akorn
Hazard
Crystallization with subpotent out of specification assay results for chlorhexidine. · FDA Class III
Units
101,952 15 mL unit dose cups
Sold at
Nationwide in the USA
Description
Crystallization with subpotent out of specification assay results for chlorhexidine.
Product
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
Manufacturer(s)
Akorn Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →