ARNICA MONTANA Recall D-0379-2025
Description: DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15
ARNICA MONTANA Recall D-0379-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0379-2025 |
| Event ID | 96639 |
| Brand | DOLODENT |
| Generic Name | ARNICA MONTANA, ASAFOEDIDA, CHAMOMILLA, HECLA LAVA, HYPERICUM |
| Manufacturer | ARNICA MONTANA, ASAFOEDIDA, CHAMOMILLA, HECLA LAVA, HYPERICUM |
| Original Package? | 1 |
| Active Substance | ARNICA MONTANA CHAMOMILE |
| Drug Route | BUCCAL |
| Distribution | DE |
| Quantity | 9504 bottles |
| Recall Reason | cGMP deviations |
| Drug Classification | Class II |
| Drug Code Info | 20250430 |
| Product NDC | 55758-400 |
| 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 | O80TY208ZW FGL3685T2X |
| Structured Product Labeling (SPL ID) | 09c282c0-4e67-8772-e063-6294a90ae4dd |
| Structured Product Labeling (SPL Set ID) | 042748e2-e755-570e-e063-6394a90a150a |
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