FDA recall D-0541-2023

Wellness BioSciences · Class II · drug

Product

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

Reason for recall

Marketed Without an Approved NDA/ANDA

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2022-04-01
Report date
2023-05-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0541-2023