The Recall Desk
LowFDA (Drugs)·D-0613-2018·Announced 2018-04-04

Akorn Recalls Subpotent Chlorhexidine Oral Rinse Kits

Akorn, Inc. is recalling 24-HOUR Oral Care q4 Kits containing subpotent Chlorhexidine Gluconate Oral Rinse due to product crystallization.

What this means for you

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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Akorn, Inc. is recalling 20,587 unit dose cups of 24-HOUR Oral Care q4 Kits with Ballard* Technology. The kits contain 2 Toothbrush Packs with CHG Solution and Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15). The product is prescription-only and was distributed nationwide in the USA.

The recall is due to subpotent drug levels caused by product crystallization, which resulted in low out-of-specification results for the chlorhexidine assay. The affected Chlorhexidine Gluconate Oral Rinse is lot # 350836, Exp 05/18. This rinse is contained within kit lots 0202522468, 0202522470, 0202518966, 0202522469, 0202522471, 0202533449, 0202533456, 0202533463, 0202543351, and 0202548200, with expiration dates of 03/18 or 04/18.

The FDA has classified this as a Class III recall, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for the specific lot numbers listed and discontinue use of the affected products.

The recalled product

Product
24-HOUR Oral Care q4 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
Hazard
Affected units
20,587

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 (13)

  • Chlorhexidine Gluconate Oral Rinse lot # 350836
  • Exp 05/18 contained within kit lot #: 0202522468
  • 0202522470
  • Exp 03/18
  • 0202518966
  • 0202522469
  • 0202522471
  • 0202533449
  • 0202533456
  • 0202533463
  • 0202543351
  • 0202548200
  • 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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