FDA recall D-0874-2016

Akorn, Inc. · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2016-03-23
Report date: 2016-06-01
Termination date: 2017-11-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0874-2016