Drug Enforcement D-1147-2023

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

Status

Terminated

Classification

Class II

Report Date

September 13, 2023

Termination Date

April 29, 2024

Product Information

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
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
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Affected product was distributed to nineteen (19) consignees within the united states.

Location & Firm

Recalling firm
AVKARE LLC
Address
615 N 1st St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1147-2023
Event ID
92868
Recall initiation date
August 11, 2023
Center classification date
September 7, 2023
Code info
Lot # P22078; Exp. 11/30/2024
More code info
—