Drug Enforcement D-0206-2025

CGMP Deviations; product intended for quarantine was inadvertently distributed

Status

Ongoing

Classification

Class II

Report Date

January 29, 2025

Termination Date

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Product Information

Product description
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
Product quantity
2756 jars
Reason for recall
CGMP Deviations; product intended for quarantine was inadvertently distributed
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide

Location & Firm

Recalling firm
First Aid Beauty Ltd
Address
70 Bridge St, Suite 203

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0206-2025
Event ID
96052
Recall initiation date
December 23, 2024
Center classification date
January 21, 2025
Code info
Lots 24D44, Exp 4/10/2026 & 24D45, 4/11/2026
More code info
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