CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness B...

FDA Recall #D-0541-2023 — Class II — April 1, 2022

Recall #D-0541-2023 Date: April 1, 2022 Classification: Class II Status: Ongoing

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

Recalling Firm

Wellness BioSciences — Houston, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2000 inhalers

Distribution

Nationwide within the United States

Code Information

All lots

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated