D-0698-2021 Class II Terminated

Recalled by Cascade Kelly Holdings LLC — Clatskanie, OR

Recall Details

Product Type
Drugs
Report Date
August 11, 2021
Initiation Date
June 30, 2021
Termination Date
July 20, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

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.

Distribution Pattern

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.

Code Information

All distributed lots within expiry