The Recall Desk
ModerateFDA (Drugs)·D-0612-2018·Announced 2018-04-04

Akorn Recalls 24-Hour Oral Care Kits Due to Low Chlorhexidine Levels

Akorn, Inc. is recalling 24-Hour Oral Care q2 Kits because the chlorhexidine gluconate oral rinse contained in some units had low potency levels.

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 III, which indicates a low probability of adverse health consequences. The hazard is a subpotent drug (low potency) rather than a toxic contamination or immediate physical injury risk, fitting the Moderate severity criteria for minor or low-risk issues.

Plain-English summary

Akorn, Inc. is recalling 48,176 unit dose cups of 24-Hour Oral Care q2 Kits with Ballard Technology. The recall involves kits containing Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15). The product is distributed nationwide in the USA.

The recall was initiated because the product experienced crystallization, which resulted in low out-of-specification results for the chlorhexidine assay. This indicates that the medication was subpotent, meaning it may not contain the full amount of the active ingredient required to be effective.

The affected product includes Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18, contained within specific kit lots. These kits were manufactured by Halyard Health, Inc. and distributed by Halyard Sales, LLC. Consumers and healthcare providers should stop using the affected kits and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, In
Manufacturer
Akorn, Inc.
Category
Drug — Oral Care / Antiseptic
Hazard
Affected units
48,176

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 (15)

  • Chlorhexidine Gluconate Oral Rinse lot # 350836
  • Exp 05/18 contained within kit lot #: 0202511399
  • 0202511400
  • 0202543553
  • Exp 03/18
  • 0202518977
  • 0202538282
  • 0202538283
  • 0202538284
  • 0202538285
  • 0202543552
  • 0202642220
  • 0202642224
  • 0202642225
  • Exp 04/18

Distribution

Distributed nationwide across the United States.

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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Same hazard · subpotent drug

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