CAPSAICIN Recall D-1147-2023
Description: 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
CAPSAICIN Recall D-1147-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1147-2023 |
| Event ID | 92868 |
| Brand | CAPSAICIN |
| Generic Name | CAPSAICIN |
| Manufacturer | CAPSAICIN |
| Original Package? | 1 |
| Active Substance | CAPSAICIN |
| Drug Route | TOPICAL |
| Distribution | Affected product was distributed to nineteen (19) consignees within the united states. |
| Quantity | 35,184 cartons |
| Recall Reason | Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste |
| Drug Classification | Class II |
| Drug Code Info | 20230913 |
| Product NDC | 50268-195 |
| Recall Initiation Date | 20230811 |
| Report Date | 20230913 |
| Classification Date | 20230907 |
| Address | 615 N 1st St Pulaski, TN 38478-2403 United States |
| Recalling Firm | AVKARE LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | S07O44R1ZM |
| Drug Application Number | part348 |
| Structured Product Labeling (SPL ID) | ef5a4143-6e96-80c8-e053-2a95a90a6565 |
| Structured Product Labeling (SPL Set ID) | ef5a3846-1d2f-7023-e053-2a95a90ad716 |
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