Drug Enforcement D-0513-2025

cGMP deviations

Status

Ongoing

Classification

Class II

Report Date

July 16, 2025

Termination Date

Product Information

Product description
Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1
Product quantity
54 tubes
Reason for recall
cGMP deviations
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
NJ, FL, MI

Location & Firm

Recalling firm
KABANA SKIN CARE
Address
685 S Arthur Ave Unit 9b, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0513-2025
Event ID
96853
Recall initiation date
March 12, 2025
Center classification date
July 10, 2025
Code info
Lot: 410-002
More code info