Earwax Removal Aid Debrox Recalled Nationwide for Improper Storage Conditions
Debrox earwax removal aid is recalled nationwide because 131 boxes of the product were stored outside label-specified conditions. Consumers should discontinue use and consult a healthcare provider if needed.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a FDA Class II recall without reported illnesses or injuries. The hazard (storage outside label specifications) is a quality control issue rather than an acute safety threat, fitting the rubric criterion for voluntary precautionary recalls or storage-related deviations.
Plain-English summary
Debrox (carbamide peroxide) earwax removal aid is being recalled nationwide. The product was stored outside the conditions specified on the drug label, constituting a Current Good Manufacturing Practice (CGMP) deviation.
The recall affects 131 boxes of Debrox (0.5 FL OZ per box, NDC 63029-321-01) distributed throughout the United States. McKesson Medical-Surgical Inc. is coordinating the recall.
Consumers who have purchased this product should discontinue use. Anyone with questions or concerns should consult a healthcare provider or contact the FDA.
The recalled product
- Product
- DEBROX (CARBAMIDE PEROXIDE)
- Brand
- DEBROX
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Otic / Earwax Removal
- Affected units
- 131
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part# 04203710478
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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