ARCTOSTAPHYLOS UVA-URSI LEAF Recall D-0384-2025
Description: Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30
ARCTOSTAPHYLOS UVA-URSI LEAF Recall D-0384-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0384-2025 |
| Event ID | 96639 |
| Brand | URODEL |
| Generic Name | CANTHARIS, CLEMATIS, CUBEBA, ECHINACEA, RANUNCULUS BULBOSUS, SABAL SERRULATA, STAPHYSAGRIA, UVA URSI |
| Manufacturer | CANTHARIS, CLEMATIS, CUBEBA, ECHINACEA, RANUNCULUS BULBOSUS, SABAL SERRULATA, STAPHYSAGRIA, UVA URSI |
| Original Package? | 1 |
| Active Substance | ARCTOSTAPHYLOS UVA-URSI LEAF CLEMATIS RECTA FLOWERING TOP |
| Drug Route | ORAL |
| Distribution | DE |
| Quantity | 10,752 bottles |
| Recall Reason | cGMP deviations |
| Drug Classification | Class II |
| Drug Code Info | 20250430 |
| Product NDC | 55758-406 |
| Recall Initiation Date | 20250415 |
| Report Date | 20250430 |
| Classification Date | 20250421 |
| Address | 650 Centerpoint BlvdN/A Historic New Castle, DE 19720-8108 United States |
| Recalling Firm | Pharmadel, LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 3M5V3D1X36 396421SP9F |
| Structured Product Labeling (SPL ID) | 0427bbc9-f4cd-0eb6-e063-6294a90a7199 |
| Structured Product Labeling (SPL Set ID) | 0427bbc9-f4cc-0eb6-e063-6294a90a7199 |
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