Aruba Aloe Balm N.V. recalls Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC…

Recall date

March 23, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0459-2024

FDA classification

Class I

Brand / firm

Aruba Aloe Balm N.V.

Sold / distributed

Nationwide in the USA

Why it was recalled

Chemical Contamination: Product manufactured with ethanol API that contains methanol

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean.