Drug Enforcement D-0541-2023

Marketed Without an Approved NDA/ANDA

Status

Ongoing

Classification

Class II

Report Date

May 3, 2023

Termination Date

Product Information

Product description
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Product quantity
2000 inhalers
Reason for recall
Marketed Without an Approved NDA/ANDA
Recall initiation reason
Initial firm notification
Other
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Wellness BioSciences
Address
9789 Katy Fwy Apt 1801, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0541-2023
Event ID
92089
Recall initiation date
April 1, 2022
Center classification date
April 21, 2023
Code info
All lots
More code info