PlainRecalls
FDA Drug Critical Class I Ongoing

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.

Reported: May 1, 2024 Initiated: March 23, 2024 #D-0459-2024

Product Description

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

Details

Recalling Firm
Aruba Aloe Balm N.V.
Units Affected
9,625 bottles
Distribution
Nationwide in the USA
Location
Oranjestad, N/A

Frequently Asked Questions

What product 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.. Recalled by Aruba Aloe Balm N.V.. Units affected: 9,625 bottles.
Why was this product recalled?
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Which agency issued this recall?
This recall was issued by the FDA Drug on May 1, 2024. Severity: Critical. Recall number: D-0459-2024.