Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm I
Summary
The FDA issued a Class I for Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Ma by Aruba Aloe Balm N.V.. Reason: Chemical Contamination: Product manufactured with ethanol API that contains methanol.
Details
Source
Drug Recall
External ID
D-0460-2024
Action Date
2024-05-01
Status
Ongoing
Category
drug
Product Description
Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5
Lot/Code Info: Lot #: 25160, Exp 4/16/2024; 25344, Exp 5/20/2024, 25580, Exp 6/15/2024; 25828, Exp 7/28/2024; 26057, Exp 8/25/2024; 26195, Exp 9/18/2024; 26471, Exp 11/25/2024; 26754, Exp 1/20/2025; 26821, Exp 2/2/2025; 27005, Exp 3/11/2025; 27518, Exp 6/22/2025; 27927, Exp 8/26/2025; 28176, Exp 10/22/2025; 28392, Exp 12/31/2025.
Quantity Affected: 5299 bottles
Reason for Recall
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-23
Company
Oranjestad, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 96 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Aruba Aloe Balm N.V. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Aruba Aloe Balm N.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aruba Aloe Balm N.V. have FDA actions?
Aruba Aloe Balm N.V. 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-0460-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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