Drug product
Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30
D-0384-2025
Product summary
- Firm
- Pharmadel, LLC
- Event
- Event 96639
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,752 bottles
- Official record key
drug-enforcement:D-0384-2025
Official wording
Reason: cGMP deviations
Code information: Lot, expiry: UDE-01, EXP: OCT 26
Distribution pattern: DE
Derived failure modes
-
Manufacturing or process control
cGMP deviations