Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild...
FDA Recall #D-1146-2023 — Class II — August 11, 2023
Product 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
Reason for Recall
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
Recalling Firm
AVKARE LLC — Pulaski, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
35,184 tubes
Distribution
Affected product was distributed to nineteen (19) consignees within the united states.
Code Information
Lot # P23025 Exp. 02/24/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated