The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0876-2016·Announced 2016-06-01

Akorn Recalls PerioRx Oral Rinse Due to Unknown Impurity

Akorn, Inc. is recalling PerioRx oral rinse because multiple batches failed impurity specifications. The product contains an unknown impurity of chlorhexidine gluconate.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential health risks.

Plain-English summary

Akorn, Inc. is recalling PerioRx (chlorhexidine gluconate) oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottles. The recall affects 294,090 mL of the product, which was distributed nationwide and in Puerto Rico. The product is prescription-only and was manufactured for Discus Dental, LLC.

The recall was initiated because multiple batches of the product failed impurity and degradation specifications. Specifically, out-of-specification results were found for an unknown impurity of chlorhexidine gluconate. The affected lots include # 627525, 628362, 628595, 629319, 629885, 630467, 32218, 632500, 633075, 632799, 345624, 345679, 347420, and 347662, with expiration dates ranging from May 2016 to September 2017.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been using the recalled product.

The recalled product

Product
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
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 (20)

  • Lot # 627525
  • Exp 5/16
  • 628362
  • Exp 6/16
  • 628595
  • Exp 7/16
  • 629319
  • Exp 8/16
  • 629885
  • Exp 9/16
  • 630467
  • Exp10/16
  • 32218
  • 632500
  • Exp 2/17
  • 633075
  • 632799
  • Exp 3/17
  • 345624
  • 345679

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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