D-0541-2023 Class II Ongoing
FDA drug recall D-0541-2023 was initiated by Wellness BioSciences on April 1, 2022 and is designated Class II. Reason for recall: Marketed Without an Approved NDA/ANDA The recall status is ongoing. Affected quantity: 2000 inhalers.
Recall Details
- Product Type
- Drugs
- Report Date
- May 3, 2023
- Initiation Date
- April 1, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2000 inhalers
Product Description
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 Pattern
Nationwide within the United States
Code Information
All lots