Product: 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.
Recall initiated: 20220629
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated