FDA (Drugs) recall action 73491
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
The agency’s own wording, quoted from the enforcement report.
Akorn, Inc. is recalling ORIS (chlorhexidine gluconate) oral rinse because multiple batches failed impurity specifications.
Akorn, Inc. is recalling PerioRx oral rinse because multiple batches failed impurity specifications. The product contains an unknown impurity of chlorhexidine gluconate.
Akorn, Inc. is recalling Chlorhexidine gluconate oral rinse due to an out-of-specification result for an unknown impurity.