Akorn Recalls Subpotent Chlorhexidine Gluconate Oral Rinse Unit Dose Cups
Akorn, Inc. is recalling Chlorhexidine Gluconate Oral Rinse unit dose cups due to product crystallization and low 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 a low risk of adverse health consequences, and the issue is a subpotent drug due to crystallization without reported injuries.
Plain-English summary
Akorn, Inc. is recalling Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count case packs (NDC 50383-720-18 or 50383-720-19). The product is prescription-only and was manufactured by Hi-Tech Pharmacal Co., Inc. in Amityville, NY. The recall involves 56,180 unit dose cups from Lot #350836 with an expiration date of 05/18.
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 may be subpotent, meaning it may not contain the full amount of the active ingredient required for effective treatment.
The affected product was distributed nationwide in the USA. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Oral Rinse
- Affected units
- 561,800
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 #: 350836
- Exp 05/18
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.
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