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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