December 2024 FDA Recall Drug by First Aid Beauty Ltd
D-0206-2025 - CGMP Deviations; product intended for quarantine was inadvertently distributed
This Class II drug recall was voluntarily initiated by First Aid Beauty Ltd on December 23, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations; product intended for quarantine was inadvertently distributed. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0206-2025
CGMP Deviations; product intended for quarantine was inadvertently distributed
12-23-2024
01-29-2025
2756 jars
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Aid Beauty Ltd
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lots 24D44, Exp 4/10/2026 & 24D45, 4/11/2026
