Recall Enforment Report D-1146-2023
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by AVKARE LLC, originally initiated on 08-11-2023 for the 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 The product was recalled due to 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. The product was distributed in Affected Product Was Distributed To Nineteen (19) Consignees Within The United States. and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-1146-2023 | 08-11-2023 | 09-13-2023 | Class II | 35,184 tubes | 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 | 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 | Terminated |
| D-1147-2023 | 08-11-2023 | 09-13-2023 | Class II | 35,184 cartons | Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478 | Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste | Terminated |
