Akorn Recalls Chlorhexidine Gluconate Oral Rinse Due to Crystallization
Akorn Inc is recalling Chlorhexidine Gluconate Oral Rinse unit dose cups because crystallization caused 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 2/5 (Moderate).
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 the product is not likely to cause adverse health consequences. The issue is a subpotent assay result due to crystallization, which is a quality defect rather than a direct safety hazard like contamination or injury.
Plain-English summary
Akorn Inc is recalling Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cups. The recall involves 541,900 unit dose cups, distributed nationwide in the USA. The affected product is identified by Lot 353394 with an expiration date of 10-2018.
The recall was initiated due to crystallization in the product, which resulted in subpotent assay results for chlorhexidine. This means the medication may not contain the intended amount of the active ingredient.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance. The product is prescription-only and was distributed by Hi-Tech Pharmacal Co. Inc.
The recalled product
- Product
- Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.
- Manufacturer
- Akorn Inc
- Category
- Drug — Oral Rinse
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 (2)
- Lot: 353394
- Exp 10-2018
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.
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