FDA recall D-0884-2023
Homeocare Laboratories, Inc. · Class II · drug
Product
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
Reason for recall
cGMP deviations
Distribution
Product was distributed USA nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2023-06-05
- Report date
- 2023-07-05
- Termination date
- 2024-09-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Yonkers, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0884-2023