FDA recall D-1065-2022
Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug
Product
Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60
Reason for recall
cGMP deviations: Temperature abuse
Distribution
USA nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2022-04-13
- Report date
- 2022-06-15
- Termination date
- 2023-11-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Richmond, VA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1065-2022