The Recall Desk
ModerateFDA (Drugs)·D-0875-2016·Announced 2016-06-01

Akorn Recalls Chlorhexidine Gluconate Oral Rinse Due to Unknown Impurity

Akorn, Inc. is recalling Chlorhexidine gluconate oral rinse due to an out-of-specification result for an unknown impurity.

What this means for you

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, which typically corresponds to a moderate severity level involving temporary or medically reversible adverse health consequences, without reported serious injuries or deaths.

Plain-English summary

Akorn, Inc. is recalling Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottles. The product is prescription-only and was manufactured by HI-TECH PHARMACAL CO., INC. The recall involves approximately 3,112,657 mL of the product distributed nationwide and in Puerto Rico.

The recall was initiated because of failed impurities and degradation specifications. Specifically, multiple batches of the Chlorhexidine gluconate showed an out-of-specification result for an unknown impurity. The affected lots have expiration dates ranging from May 2016 to July 2017.

Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16
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 # 627528
  • 627763
  • 627766
  • 627921
  • 627924
  • 627927
  • 627930
  • 627933
  • 627953
  • 627956
  • 627959
  • 628040
  • Exp 5/16
  • 628148
  • 628151
  • 628230
  • 628232
  • 628365
  • Exp 6/16
  • 628589

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 →

Related recalls

Same manufacturer · Akorn, Inc.

See all →

Same hazard · impurity

See all →