Drug product
Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.
D-0813-2018
Product summary
- Event
- Event 80042
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,815 tubes
- Official record key
drug-enforcement:D-0813-2018
Official wording
Reason: GMP Deviations
Code information: Lot #: KU455-4, Exp.10/30/2020
Distribution pattern: Within the United States and Puerto Rico
Derived failure modes
-
Manufacturing or process control
GMP Deviations