Why it was recalled
Marketed Without an Approved NDA/ANDA
Product description
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0541-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 1, 2022
- FDA report date
- May 3, 2023
- Quantity
- 2000 inhalers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wellness BioSciences
Original FDA data
Every field from FDA enforcement report D-0541-2023, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 92089
- Address
- 9789 Katy Fwy Apt 1801
- Code information
- All lots
- Postal code
- 77024-1378
- Report date
- May 3, 2023
- Product type
- Drugs
- Recall number
- D-0541-2023
- Classification
- Class II
- Recalling firm
- Wellness BioSciences
- Product quantity
- 2000 inhalers
- Reason for recall
- Marketed Without an Approved NDA/ANDA
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Apr 1, 2022
- Initial firm notification
- Other
- Center classification date
- Apr 21, 2023