Akorn, Inc. recalls 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Glucon
Recalled April 4, 2018 · FDA recall D-0612-2018 · Akorn
Hazard
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. · FDA Class III
Units
48,176 unit dose cups
Sold at
Nationwide in the USA
Description
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Product
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.
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →