Class II · Moderate risk
Skincell Mole & Skin Corrector Serum
Marketed Without An Approved NDA/ANDA; Unapproved new drug
CBD Metered Dose Inhaler
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed Without an Approved NDA/ANDA
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
- Recalling firm
- Wellness BioSciences
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0541-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other unapproved drug recalls from 2022
All unapproved drug recalls
Class II · Moderate risk
Skincell Mole & Skin Corrector Serum
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class II · Moderate risk
Launch Sequence Aphrodisia Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Launch Sequence Euphoria Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
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