Akorn Inc recalls Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray…

Recall date

July 12, 2017

Source

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

Recall number

D-1088-2017

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

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.