The Recall Desk

FDA (Drugs) recall action 88222

Cascade Kelly Holdings LLC recalled 2 products on 2021-08-11

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-08-11
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: Does not meet monograph for denaturant.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • ModerateFDA (Drugs)··2021-08-11

    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.

    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
    Category
    Distribution
    9 states
  • ModerateFDA (Drugs)··2021-08-11

    Global Hand Sanitizer Recalled Due to Denaturant Deficiency

    Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with moisturizer because the product does not meet the required denaturant specifications for alcohol-based antiseptics.

    Product
    Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01
    Category
    Distribution
    9 states