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
D-0206-2025
Product summary
- Event
- Event 96052
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2756 jars
- Official record key
drug-enforcement:D-0206-2025
Official wording
Reason: CGMP Deviations; product intended for quarantine was inadvertently distributed
Code information: Lots 24D44, Exp 4/10/2026 & 24D45, 4/11/2026
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations