SODIUM FLUORIDE Recall D-1146-2023
Description: Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478
SODIUM FLUORIDE Recall D-1146-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1146-2023 |
| Event ID | 92868 |
| Brand | SODIUM FLOURIDE |
| Generic Name | SODIUM FLUORIDE |
| Manufacturer | SODIUM FLUORIDE |
| Original Package? | 1 |
| Active Substance | SODIUM FLUORIDE |
| Drug Route | DENTAL |
| Distribution | Affected product was distributed to nineteen (19) consignees within the united states. |
| Quantity | 35,184 tubes |
| Recall Reason | Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste |
| Drug Classification | Class II |
| Drug Code Info | 20230913 |
| Product NDC | 42291-741 |
| Drug UPC | 0342291741515 |
| Recall Initiation Date | 20230811 |
| Report Date | 20230913 |
| Classification Date | 20230907 |
| Address | 615 N 1st St Pulaski, TN 38478-2403 United States |
| Recalling Firm | AVKARE LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 8ZYQ1474W7 |
| Structured Product Labeling (SPL ID) | eaedb2a2-ca74-27bc-e053-2995a90a9911 |
| Structured Product Labeling (SPL Set ID) | 92fef2e0-f9f2-8b0f-e053-2995a90a096a |
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