The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0874-2016·Announced 2016-06-01

Akorn Recalls ORIS Chlorhexidine Oral Rinse Due to Impurity

Akorn, Inc. is recalling ORIS (chlorhexidine gluconate) oral rinse because multiple batches failed impurity specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a failed impurity specification without reported harm, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Akorn, Inc. is recalling ORIS (chlorhexidine gluconate) oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottles. The product is prescription-only and was manufactured for DENTSPLY Professional. The recall involves a total quantity of 33,862 mL.

The recall was initiated because multiple batches of the product failed impurities and degradation specifications, specifically showing an out-of-specification result for an unknown impurity of Chlorhexidine gluconate. The affected lots are #628146 (Exp 6/16), #629690 (Exp 9/16), and #348295 (Exp 10/17).

The product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

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
Manufacturer
Akorn, Inc.
Category
Drug — Oral Rinse
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot # 628146
  • Exp 6/16
  • 629690
  • Exp 9/16
  • 348295
  • Exp 10/17

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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