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

Class I - Dangerous
💊 Drugs Recalled: July 12, 2017 Akorn Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: 0202635072, 0202635073, EXP 06-2018; 0202630205, 0202630206, EXP 07-2018; 0202630203, 0202630204, 0202642217, 0202642218, 0202642219, 0202647410, 0202647411, EXP 08-2018; 0202647409, 0202647412, 0202653431, 0202653432, EXP 09-2018.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Akorn Inc
Reason for Recall:
Crystallization with subpotent out of specification assay results for chlorhexidine.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lots: 0202635072, 0202635073, EXP 06-2018; 0202630205, 0202630206, EXP 07-2018; 0202630203, 0202630204, 0202642217, 0202642218, 0202642219, 0202647410, 0202647411, EXP 08-2018; 0202647409, 0202647412, 0202653431, 0202653432, EXP 09-2018.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1090-2017

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