Drug product
AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment With Oat and Sea Whip, Net Wt. 5 OZ. (141 g)
D-0978-2022
Product summary
- Event
- Event 90270
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0978-2022
Official wording
Reason: cGMP deviations: product stored outside of labeled temperature requirements.
Code information: SKUs 2097153
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations