Recall Enforment Report D-0697-2021
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Cascade Kelly Holdings LLC, originally initiated on 06-30-2021 for the 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 The product was recalled due to cgmp deviations: does not meet monograph for denaturant.. The product was distributed in 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. and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0697-2021 | 06-30-2021 | 08-11-2021 | Class II | 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 | CGMP Deviations: Does not meet monograph for denaturant. | Terminated | |
| D-0698-2021 | 06-30-2021 | 08-11-2021 | Class II | 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 | CGMP Deviations: Does not meet monograph for denaturant. | Terminated |
