FDA recall D-1318-2022
Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug
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.
Distribution
Nationwide in the USA.
Key facts
- Status
- Terminated
- Initiation date
- 2022-06-29
- Report date
- 2022-08-17
- Termination date
- 2024-02-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Richmond, VA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1318-2022