FDA Recall D-0541-2023
Wellness BioSciences · Houston, TX
Class II Ongoing 1504 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0541-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Other
- Distribution
- Nationwide within the United States
- Recall initiated
- 2022-04-01
- Classified by FDA Center
- 2023-04-21
- FDA published
- 2023-05-03
- Recalling firm
- Wellness BioSciences
- Firm location
- Houston, TX
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.