24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97014.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202522468, 0202522470, Exp 03/18; 0202518966, 0202522469, 0202522471, 0202533449, 0202533456, 0202533463, 0202543351, 0202548200, Exp 04/18
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97014.
Product Codes/Lot Numbers:
Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202522468, 0202522470, Exp 03/18; 0202518966, 0202522469, 0202522471, 0202533449, 0202533456, 0202533463, 0202543351, 0202548200, Exp 04/18
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0613-2018
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CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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