FDAFDA · Food and drugs·Recall number D-1089-2017
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
Published August 23, 2017 · Recall initiated: July 12, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization with subpotent out of specification assay results for chlorhexidine.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn Inc
- Distributor
- Nationwide in the USA
- Lot
- Lots: 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209, EXP 06-2018; 0202642227, 0202642228, 0202647413, 0202647414, 0202653433, 0202653434, EXP 07-2018.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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