HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6
Summary
The FDA issued a Class II for HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanit by Charles Paint Research Inc. Reason: CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits..
Details
Source
Drug Recall
External ID
D-0792-2021
Action Date
2021-09-15
Status
Terminated
Category
drug
Product Description
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131
Lot/Code Info: Lot# 20-160, Exp 06/11/2022
Quantity Affected: 600 gallons
Reason for Recall
CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.
Distribution
Distributed in Michigan
Type: Voluntary: Firm initiated
Recall Initiated: 2020-09-02
Company
Kansas City, MO
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 26 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Charles Paint Research Inc 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 (Charles Paint Research Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Charles Paint Research Inc have FDA actions?
Charles Paint Research Inc 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-0792-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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