Drug product
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
D-1146-2023
Product summary
- Firm
- AVKARE LLC
- Event
- Event 92868
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35,184 tubes
- Official record key
drug-enforcement:D-1146-2023
Official wording
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
Code information: Lot # P23025 Exp. 02/24/2025
Distribution pattern: Affected product was distributed to nineteen (19) consignees within the united states.
Derived failure modes
-
Unknown
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