Akorn, Inc. recalls ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured fo…

Recall date

March 23, 2016

Source

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

Recall number

D-0874-2016

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

ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O