D-1146-2023 Class II Terminated
FDA drug recall D-1146-2023 was initiated by AVKARE LLC on August 11, 2023 and is designated Class II. 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 Tooth… The recall status is terminated (terminated April 29, 2024). Affected quantity: 35,184 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- September 13, 2023
- Initiation Date
- August 11, 2023
- Termination Date
- April 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,184 tubes
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
Distribution Pattern
Affected product was distributed to nineteen (19) consignees within the united states.
Code Information
Lot # P23025 Exp. 02/24/2025