PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 13, 2023 Initiated: August 11, 2023 #D-1146-2023

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

Details

Recalling Firm
AVKARE LLC
Units Affected
35,184 tubes
Distribution
Affected product was distributed to nineteen (19) consignees within the united states.
Location
Pulaski, TN

Frequently Asked Questions

What product was recalled?
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. Recalled by AVKARE LLC. Units affected: 35,184 tubes.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Drug on September 13, 2023. Severity: Moderate. Recall number: D-1146-2023.