Multi-event August 2023 FDA Recall Sodium Flouride by Avkare Llc
This Multi-event Class II drug recall was voluntarily initiated by Avkare Llc on August 11, 2023 for the product Sodium Flouride. The FDA reported the reason for recall as 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. The product was distributed in Affected product was distributed to nineteen (19) consignees within the united states. and the recall is currently terminated.
Reported Recall Events
Recall Number: 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
08-11-2023
09-13-2023
35,184 tubes
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AVKARE LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Affected product was distributed to nineteen (19) consignees within the united states.
04-29-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# P23025 Exp. 02/24/2025
Affected Packages Involved in this Recall
Recall Number: D-1147-2023
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
08-11-2023
09-13-2023
35,184 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AVKARE LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Affected product was distributed to nineteen (19) consignees within the united states.
04-29-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
