Akorn Inc recalls Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufacture…

Recall date

July 12, 2017

Source

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

Recall number

D-1089-2017

FDA classification

Class III

Brand / firm

Akorn Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

Crystallization with subpotent out of specification assay results for chlorhexidine.

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

What was recalled

Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012