Drug recall
Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC…
FDA recall event 92868 · Class II · AVKARE LLC
Key facts
| Event ID | 92868 |
|---|---|
| Recall numbers | D-1146-2023, D-1147-2023 |
| Recalling firm | AVKARE LLC |
| Product type | Drugs |
| Products | 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, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| 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…, Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste |
| Initiation date | Aug 11, 2023 |
| Report date | Sep 13, 2023 |
| Termination date | Apr 29, 2024 |
| City | Pulaski |
| State | TN |
| Country | United States |
| FEI number | 3007255004 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: