FDA recall D-0384-2025

Pharmadel, LLC · Class II · 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

Reason for recall

cGMP deviations

Distribution

DE

Key facts

Status
Terminated
Initiation date
2025-04-15
Report date
2025-04-30
Termination date
2026-01-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Historic New Castle, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0384-2025