FDA recall D-66402-001
Tolmar, Inc. · Class III · drug
Product
Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
Reason for recall
Subpotent
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2013-09-23
- Report date
- 2013-10-30
- Termination date
- 2014-04-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Fort Collins, CO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66402-001