FDA recall D-0460-2024

Aruba Aloe Balm N.V. · Class I · drug

Product

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

Reason for recall

Chemical Contamination: Product manufactured with ethanol API that contains methanol

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2024-03-23
Report date
2024-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oranjestad, N/A, Aruba

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0460-2024