Drug product
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
D-0380-2025
Product summary
- Firm
- Pharmadel, LLC
- Event
- Event 96639
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27,648 bottles
- Official record key
drug-enforcement:D-0380-2025
Official wording
Reason: cGMP deviations
Code information: Lot, expiry: DEE-01, EXP: OCT 26; DEE-02 EXP: FEB 27
Distribution pattern: DE
Derived failure modes
-
Manufacturing or process control
cGMP deviations