Drug product
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
D-0195-2026
Product summary
- Event
- Event 97820
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4890 bottles
- Official record key
drug-enforcement:D-0195-2026
Official wording
Reason: CGMP Deviations
Code information: Lot D54447, exp 11/30/2027
Distribution pattern: CA, CO, FL, PR, WA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations