# FDA recall D-1147-2023

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

## Product

Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478

## Reason for recall

Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain 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-1147-2023
- **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-1147-2023

## Citation

> AI Analytics. FDA recall D-1147-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1147-2023. Source: US FDA. Licensed CC0.

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