PlainRecalls
FDA Drug Moderate Class II Terminated

Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.

Reported: August 17, 2022 Initiated: June 29, 2022 #D-1318-2022

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.

Details

Units Affected
131 boxes
Distribution
Nationwide in the USA.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 131 boxes.
Why was this product recalled?
CGMP Deviations: products were stored outside the drug label specifications.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 17, 2022. Severity: Moderate. Recall number: D-1318-2022.