The Recall Desk
ModerateFDA (Drugs)·D-1318-2022·Announced 2022-08-17

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
Hazard
  • improper-storage
  • cgmp-deviation

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.

Related recalls

Same category