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Recall Observatory FDA recall evidence

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

D-0460-2024

March 23, 2024

Class I

Product summary

Firm
Aruba Aloe Balm N.V.
Event
Event 94335
Status
Ongoing
Classification
Class I
Quantity
5299 bottles
Official record key
drug-enforcement:D-0460-2024

Official wording

Reason: Chemical Contamination: Product manufactured with ethanol API that contains methanol

Code information: 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.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination