Sodium Flouride Paste, Dentifrice
FDA Recall NDC 42291-741
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sodium Flouride (NDC 42291-741). A significant event, classified as Class II, was initiated on Aug 11, 2023 by Avkare. The reported reason for this action was: "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"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
August 2023 Class II 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
Recall Number
Class II Terminated
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
Aug 11, 2023
Sep 13, 2023
35,184 tubes
Recall Profile & Regulatory Data
Event ID
92868
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AVKARE LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Affected product was distributed to nineteen (19) consignees within the united states.
Termination Date
Apr 29, 2024
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
Batch or Lot Expiration Information
Lot# P23025 Exp. 02/24/2025
Affected Packages Involved in this Recall
42291-741-51Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
