Akorn, Inc. recalls Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups…

Recall date

March 29, 2018

Source

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

Recall number

D-0611-2018

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

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.