Drug product
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
D-0884-2023
Product summary
- Event
- Event 92453
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,850 tottles
- Official record key
drug-enforcement:D-0884-2023
Official wording
Reason: cGMP deviations
Code information: Lot # 2423, exp. date Nov-24; 2445, exp. date Apr-25
Distribution pattern: Product was distributed USA nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP deviations