Drug product
Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8
D-0194-2026
Product summary
- Event
- Event 97820
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0194-2026
Official wording
Reason: CGMP Deviations
Code information: Lot D53681, exp 03/31/2027
Distribution pattern: CA, CO, FL, PR, WA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations