The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1089-2017·Announced 2017-08-23

Akorn Recalls Halyard Chlorhexidine Oral Rinse Due to Crystallization

Akorn Inc is recalling Halyard 24-Hour Oral Care Kits containing chlorhexidine gluconate oral rinse due to crystallization and subpotent assay results.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which indicates a violation of labeling or FDA regulations that is not likely to cause adverse health consequences. The hazard is subpotency (reduced effectiveness) rather than toxicity or injury.

Plain-English summary

Akorn Inc is voluntarily recalling Halyard 24-Hour Oral Care Kit q2, which contains 2x15 mL Unit Dose Cups of 0.12% Chlorhexidine Gluconate Oral Rinse. The recall involves 40,978 unit dose cups distributed nationwide in the USA. The product was manufactured by Halyard Health Inc. and distributed by Halyard Sales, LLC.

The recall was initiated because of crystallization and subpotent out-of-specification assay results for chlorhexidine. This means the active ingredient in the affected units may not be at the intended strength, potentially reducing the product's effectiveness.

Consumers and healthcare facilities should stop using the affected product and contact Akorn Inc for further instructions. The affected lots are identified by specific lot numbers and expiration dates of 06-2018 and 07-2018 as listed in the recall notice.

The recalled product

Product
Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012
Manufacturer
Akorn Inc
Category
Drug — Oral Rinse
Hazard
Affected units
40,978

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 (14)

  • Lots: 0202623109
  • 0202623110
  • 0202623111
  • 0202630207
  • 0202630208
  • 0202630209
  • EXP 06-2018
  • 0202642227
  • 0202642228
  • 0202647413
  • 0202647414
  • 0202653433
  • 0202653434
  • EXP 07-2018.

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 →

Related recalls

Same manufacturer · Akorn Inc

See all →

Same hazard · subpotency

See all →

Similar recalls