FDA Recall Terminated Historical recordClass 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
- Reason
- Crystallization with subpotent out of specification assay results for chlorhexidine.
- Published
- August 23, 2017
- Distribution
- Nationwide
