Aruba Aloe Balm N.V.

FDA Regulatory Profile

Aruba Aloe Balm N.V. appears in FDA public data with 2 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0460-2024, Class I) was initiated on March 23, 2024.

Summary

Total Recalls
2 (2 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0460-2024Class IAruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba March 23, 2024
D-0459-2024Class IAlcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL)March 23, 2024