Drug product
AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g)
D-0976-2022
Product summary
- Event
- Event 90270
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0976-2022
Official wording
Reason: cGMP deviations: product stored outside of labeled temperature requirements.
Code information: SKUs 2024222
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations