Drug product
Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02
D-0187-2026
Product summary
- Event
- Event 97820
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 874 tubes
- Official record key
drug-enforcement:D-0187-2026
Official wording
Reason: CGMP Deviations
Code information: Lot D53950, exp 5/31/2027
Distribution pattern: CA, CO, FL, PR, WA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations