Drug product
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
D-0513-2025
Product summary
- Firm
- KABANA SKIN CARE
- Event
- Event 96853
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 54 tubes
- Official record key
drug-enforcement:D-0513-2025
Official wording
Reason: cGMP deviations
Code information: Lot: 410-002
Distribution pattern: NJ, FL, MI
Derived failure modes
-
Manufacturing or process control
cGMP deviations