Akorn, Inc. recalls Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH…

Recall date

March 23, 2016

Source

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

Recall number

D-0875-2016

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16