CareFusion Recalls Chlorhexidine Gluconate Surgical Hand Scrub for Concentration Issues
CareFusion 213, LLC is recalling Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, because it contains higher concentrations of available chlorhexidine gluconate than required.
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 remote possibility of adverse health consequences. The issue is a deviation from the monograph regarding concentration, which fits the criteria for a moderate severity labeling or formulation error without reported serious injury.
Plain-English summary
CareFusion 213, LLC is recalling Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC (NDC 57613-007-25). The recall involves 20,556,000 scrubs distributed nationwide, as well as in Mexico and the Philippines. All lots are affected.
The product is being recalled because it does not meet the monograph for Chlorhexidine Gluconate Surgical Scrub Brush. Specifically, the product contains higher concentrations of available chlorhexidine gluconate than specified.
The U.S. Food and Drug Administration has classified this as a Class III recall. Consumers and healthcare facilities should stop using the product and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Topical Antiseptic
- Affected units
- 20,556,000
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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