FDA-Drug2017-08-23Class III
Halyard 24-Hour Oral Care Kit q2, 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 # 97012
Akorn Inc
Hazard
Crystallization with subpotent out of specification assay results for chlorhexidine.
Sold states
Nationwide in the USA
Affected count
40,978 unit dose cups
Manufactured in
1925 W Field Ct, N/A, Lake Forest, IL, United States
Products
Halyard 24-Hour Oral Care Kit q2, 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 # 97012
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1089-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief