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D-0697-2021 Class II Terminated

Recalled by Cascade Kelly Holdings LLC — Clatskanie, OR

FDA drug recall D-0697-2021 was initiated by Cascade Kelly Holdings LLC on June 30, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Does not meet monograph for denaturant. The recall status is terminated (terminated July 20, 2022).

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, 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 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