CLASS II Drug recall · Reported 17 Aug 2022 · FDA Enforcement Report
Debrox, Carbamide Peroxide, Earwax Removal Aid bottle recalled
Mckesson Medical-Surgical Inc. Corporate Office is recalling Debrox, Carbamide Peroxide, Earwax Removal Aid bottle per box), MedTech Products Inc, distributed nationwide in the US. The recall was initiated on 29 Jun 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1318-2022
- FDA event ID
- 90553
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Brand
- Debrox
- Manufacturer
- Medtech Products Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2022
- FDA classified
- 5 Aug 2022
- Reported
- 17 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 29 Jun 2022 | Recall initiated by company | |
| 5 Aug 2022 | Classified by FDA | +37 days |
| 17 Aug 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: products were stored outside the drug label specifications.
Product as listed by the FDA
Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Is Debrox, Carbamide Peroxide, Earwax Removal Aid bottle per box), MedTech Products Inc recalled?
Yes. Mckesson Medical-Surgical Inc. Corporate Office recalled Debrox, Carbamide Peroxide, Earwax Removal Aid bottle per box), MedTech Products Inc on 29 Jun 2022. The recall is Class II and its status is Terminated. Recall number D-1318-2022.
Why was it recalled?
CGMP Deviations: products were stored outside the drug label specifications.
Which lots are affected?
Part# 04203710478
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mckesson Medical-Surgical Inc. Corporate Office
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|---|---|---|---|---|---|
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Other Carbamide Peroxide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Good Neighbor Pharmacy, Carbamide Peroxide 5%, a) Kit recalledGood Neighbor Pharmacy Earwax Removal | Bell Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Audiologist's Choice, Carbamide Peroxide 5% a) Kit recalledAudiologists Choice Earwax Removal System | Bell Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | TopCare Health, Carbamide Peroxide 5% a) Kit recalledTopcare Earwax Removal Kit | Bell Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | CVS Health, Carbamide Peroxide, 5%, a) Bottle recalledCvs Health Earwax Removal Drops Earwax Removal Aid | Bell Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | meijer, Carbamide Peroxide 5%, Washer Bulb included recalledMeijer Earwax Removal Kit | Bell Pharmaceuticals | Potency & Assay | Nationwide |