Drug product
festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen Distributed by: festpak - Austin, TX 78732 Made in China
D-1533-2019
Product summary
- Event
- Event 83018
- Status
- Terminated
- Classification
- Class III
- Quantity
- 20, 000
- Official record key
drug-enforcement:D-1533-2019
Official wording
Reason: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Code information: Lot #: 20181008, Exp 10/07/2020; 20181009, Exp 10/08/2020
Distribution pattern: Foreign manufacturer located in China and distributed to seven consignees located in China.
Derived failure modes
-
Manufacturing or process control
CGMP deviations