Drug product
Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128
D-0812-2018
Product summary
- Event
- Event 80042
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,156 tubes
- Official record key
drug-enforcement:D-0812-2018
Official wording
Reason: GMP Deviations
Code information: Lot #: KU455-2, Exp. 11/09/2020; KU455-6, Exp.11/26/2020
Distribution pattern: Within the United States and Puerto Rico
Derived failure modes
-
Manufacturing or process control
GMP Deviations