PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701

Recall Number: D-0876-2016

Firm: Akorn, Inc.

Classification: Class II

Status: Terminated

Report Date: 20160601

Initiation Date: 20160323

Termination Date: 20171130

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

PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701