FDA recall D-0459-2024

Product

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.

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-0459-2024