FDA-Drug2018-04-04Class III
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.
Akorn, Inc.
Hazard
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Sold states
Nationwide in the USA
Affected count
20,587 unit dose cups
Manufactured in
1925 W Field Ct Ste 300, Lake Forest, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0613-2018Don't want to check this manually?
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