FDA recall D-0206-2025

First Aid Beauty Ltd · Class II · drug

Product

First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6

Reason for recall

CGMP Deviations; product intended for quarantine was inadvertently distributed

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2024-12-23
Report date
2025-01-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Newton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0206-2025