Recalls / Class II
Class IID-1146-2023
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
- Brand name
- Sodium Flouride
- Generic name
- Sodium Fluoride
- Active ingredient
- Sodium Fluoride
- Route
- Dental
- NDC
- 42291-741
- Affected lot / code info
- Lot # P23025 Exp. 02/24/2025
Why it was 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
Recalling firm
- Firm
- AVKARE LLC
- Manufacturer
- AvKARE
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 35,184 tubes
- Distribution pattern
- Affected product was distributed to nineteen (19) consignees within the united states.
Timeline
- Recall initiated
- 2023-08-11
- FDA classified
- 2023-09-07
- Posted by FDA
- 2023-09-13
- Terminated
- 2024-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1146-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.