AVKARE LLC: Drug Recall

Recall #D-1147-2023 · 08/11/2023

Class II: Risk

Recall Details

Recall Number: D-1147-2023
Classification: Class II
Product Type: Drug
Recalling Firm: AVKARE LLC
Status: Terminated
Date Initiated: 08/11/2023
Location: Pulaski, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 35,184 cartons

Reason for Recall

Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

Product 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

Distribution Pattern

Affected product was distributed to nineteen (19) consignees within the united states.

Other Recalls by AVKARE LLC

Class II: Risk 08/11/2023

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
Class III: Low Risk 06/13/2023

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class II: Risk 12/22/2022

Failed impurities/degradation specifications: Out of specification for unknown impurities.

View all recalls by AVKARE LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.