# FDA recall D-1146-2023

> **AVKARE LLC** · Class II · drug recall initiated 2023-08-11.

## 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

- **Recall number:** D-1146-2023
- **Recalling firm:** AVKARE LLC
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-1146-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1146-2023. Source: US FDA. Licensed CC0.

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