Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Al
Summary
The FDA issued a Class II for Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-steril by Cascade Kelly Holdings LLC. Reason: CGMP Deviations: Does not meet monograph for denaturant..
Details
Source
Drug Recall
External ID
D-0698-2021
Action Date
2021-08-11
Status
Terminated
Category
drug
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
Lot/Code Info: All distributed lots within expiry
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-30
Company
Clatskanie, OR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 21 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Cascade Kelly Holdings LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cascade Kelly Holdings LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cascade Kelly Holdings LLC have FDA actions?
Cascade Kelly Holdings LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0698-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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