Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Produc...
FDA Recall #D-1318-2022 — Class II — June 29, 2022
Product Description
Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.
Reason for Recall
CGMP Deviations: products were stored outside the drug label specifications.
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office — Richmond, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
131 boxes
Distribution
Nationwide in the USA.
Code Information
Part# 04203710478
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated