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Recall Observatory FDA recall evidence

Drug product

Herpes V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

D-1135-2020

March 24, 2020

Class II

Product summary

Firm
Herbal Doctor Remedies
Event
Event 85341
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1135-2020

Official wording

Reason: CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

Code information: All lots within expiry

Distribution pattern: Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    misbranded
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations