FDA Recall D-0459-2024
Aruba Aloe Balm N.V. · Oranjestad, N/A
Class I — life-threatening Ongoing 782 days on record
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
Recall record
- Recall number
D-0459-2024- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide in the USA
- Recall initiated
- 2024-03-23
- Classified by FDA Center
- 2024-04-23
- FDA published
- 2024-05-01
- Recalling firm
- Aruba Aloe Balm N.V.
- Firm location
- Oranjestad, N/A, Aruba
Operational response
A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.
For the official FDA enforcement record, see FDA's Recall Search.