Drug product
StellaLife VEGA Oral Gel Rinse (In equal parts of: Azadirachta Indica 1x, Calendula Officinalis 1x, Echinacea Purpurea 1x, Plantago Major 1x), packaged in 1000 mL white plastic bottle.
D-0505-2020
Product summary
- Event
- Event 84213
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 bottle/
- Official record key
drug-enforcement:D-0505-2020
Official wording
Reason: CGMP Deviations: products were not manufactured under current good manufacturing practices.
Code information: Lot # 29488
Distribution pattern: Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Derived failure modes
-
Manufacturing or process control
CGMP Deviations