Akorn, Inc. recalls 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluco…

Recall date

March 29, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0613-2018

FDA classification

Class III

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.