CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Summary
The FDA issued a Class II for CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sp by Wellness BioSciences. Reason: Marketed Without an Approved NDA/ANDA.
Details
Source
Drug Recall
External ID
D-0541-2023
Action Date
2023-05-03
Status
Ongoing
Category
drug
Product Description
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Lot/Code Info: All lots
Quantity Affected: 2000 inhalers
Reason for Recall
Marketed Without an Approved NDA/ANDA
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-01
Company
Houston, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Wellness BioSciences) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wellness BioSciences have FDA actions?
This is the only FDA action we have on record for Wellness BioSciences in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0541-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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