Global Hand Sanitizer with Moisturizer Recalled for Denaturant Deviation
Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with Moisturizer due to failure to meet the required denaturant specification. The product was distributed to affiliated facilities and third-party recipients in nine states.
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: This is an FDA Class II recall involving a manufacturing practice deviation (denaturant specification not met). The source text does not report any illnesses, injuries, or specific safety incidents, and the hazard remains theoretical rather than realized.
Plain-English summary
Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with Moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL (NDC 80253-001-02), manufactured by Cascade Kelly Holdings LLC.
The recall is due to a current Good Manufacturing Practice (CGMP) deviation: the product does not meet the monograph requirement for denaturant.
The product was distributed to the firm's affiliated facilities and donated to third-party recipients located in Connecticut, Massachusetts, Maine, North Dakota, New York, Oregon, Pennsylvania, Texas, and Vermont. All distributed lots remain within their expiration dates.
Consumers should discontinue use of this product and contact their healthcare provider if they have questions about potential exposure.
The recalled product
- Product
- Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-02
- Manufacturer
- Cascade Kelly Holdings LLC
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 distributed lots within expiry
Distribution
Part of a larger recall action
This product is one of 2 recalled by Cascade Kelly Holdings LLC 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 2 products in this recall →Related recalls
Same manufacturer · Cascade Kelly Holdings LLC
See all →- ModerateGlobal Hand Sanitizer Recalled Due to Denaturant Deficiency
FDA (Drugs) · 2021-08-11
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