Sage Products Recalls Chlorhexidine Gluconate Cloth Due to Cross Contamination
Sage Products, LLC is recalling 165,536 packages of 2% Chlorhexidine Gluconate Cloth due to cross-contamination with other products.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Sage Products, LLC is voluntarily recalling 165,536 packages of 2% Chlorhexidine Gluconate Cloth, Non-sterile, 6 Disposable cloths. The product is identified by NDC 53462-705-26 and is distributed nationwide in the United States.
The recall is being conducted due to cross-contamination with other products. The specific affected lot is Lot 108491 with case sequence numbers 14841 through 20013.
Consumers should stop using the product and contact Sage Products, LLC for further instructions or a refund.
The recalled product
- Product
- CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE GLUCONATE)
- Brand
- CHLORHEXIDINE GLUCONATE
- Manufacturer
- Sage Products, LLC
- Category
- Drug — Topical Antiseptic
- Hazard
- Affected units
- 165,536
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)
- Lot 108491 with case sequence numbers 14841 through 20013.
UPCs (1)
- 0618029850607
Distribution
Distributed nationwide across the United States.
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