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Recall Observatory FDA recall evidence

Drug product

CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx

D-0541-2023

April 01, 2022

Class II

Product summary

Firm
Wellness BioSciences
Event
Event 92089
Status
Ongoing
Classification
Class II
Quantity
2000 inhalers
Official record key
drug-enforcement:D-0541-2023

Official wording

Reason: Marketed Without an Approved NDA/ANDA

Code information: All lots

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA