Capsaicin Cream
FDA Recall NDC 50268-195
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Capsaicin (NDC 50268-195). A significant event, classified as Class II, was initiated on Aug 11, 2023 by Avpak. The reported reason for this action was: "Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Aug 11, 2023
Sep 13, 2023
35,184 cartons
Recall Profile & Regulatory Data
Event ID
92868
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AVKARE LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Affected product was distributed to nineteen (19) consignees within the united states.
Termination Date
Apr 29, 2024
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
Batch or Lot Expiration Information
Lot# P22078; Exp. 11/30/2024
Affected Packages Involved in this Recall
50268-195-60Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
