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Recall Observatory FDA recall evidence

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

November 08, 2019

Class II

Product summary

Firm
Washington Homeopathic Products, Inc.
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

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations