FDA recall D-1146-2023

AVKARE LLC · Class II · 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

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

Distribution

Affected product was distributed to nineteen (19) consignees within the united states.

Key facts

Status: Terminated
Initiation date: 2023-08-11
Report date: 2023-09-13
Termination date: 2024-04-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1146-2023