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Recall Observatory FDA recall evidence

Drug product

Asthma Balm 60 gram, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

D-1588-2019

July 12, 2019

Class II

Product summary

Firm
Herbal Doctor Remedies
Event
Event 83437
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1588-2019

Official wording

Reason: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.

Code information: All lots within expiry

Distribution pattern: Nationwide within the United States and Brazil and on the internet

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations