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

FDA recall notice · announced August 11, 2021 · Cascade Kelly

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

CGMP Deviations: Does not meet monograph for denaturant.

Notes

Distribution: Distributed to the firm's affiliated facilities and donated third party recipients located in the following states: CT, MA, ME, ND, NY, OR, PA, TX, VT.
Lot/code information: All distributed lots within expiry
Status: Terminated
Products in this recall event:
- 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 (D-0697-2021)
- 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 (D-0698-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.