FDA recall D-0697-2021

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

Reason for recall

CGMP Deviations: Does not meet monograph for denaturant.

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.

Key facts

Status

Terminated

Initiation date

2021-06-30

Report date

2021-08-11

Termination date

2022-07-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Clatskanie, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0697-2021