FDAFDA · Food and drugs·Recall number D-0612-2018
24-HOUR Oral Care q2 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 97012.
Published April 4, 2018 · Recall initiated: March 29, 2018
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
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202511399, 0202511400, 0202543553, Exp 03/18; 0202518977, 0202538282, 0202538283, 0202538284, 0202538285, 0202543552, 0202642220, 0202642224, 0202642225, Exp 04/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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