Drug Enforcement D-1146-2023

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

Status

Terminated

Classification

Class II

Report Date

September 13, 2023

Termination Date

April 29, 2024

Product Information

Product description
Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478
Product quantity
35,184 tubes
Reason for recall
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
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-1146-2023
Event ID
92868
Recall initiation date
August 11, 2023
Center classification date
September 7, 2023
Code info
Lot # P23025 Exp. 02/24/2025
More code info
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