Product Safety Recalls

Product Recall Tracker

SODIUM FLUORIDE Recall D-1146-2023

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

SODIUM FLUORIDE Recall D-1146-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1146-2023
Event ID92868
BrandSODIUM FLOURIDE
Generic NameSODIUM FLUORIDE
ManufacturerSODIUM FLUORIDE
Original Package?1
Active SubstanceSODIUM FLUORIDE
Drug RouteDENTAL
DistributionAffected product was distributed to nineteen (19) consignees within the united states.
Quantity35,184 tubes
Recall ReasonCases 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
Drug ClassificationClass II
Drug Code Info20230913
Product NDC42291-741
Drug UPC0342291741515
Recall Initiation Date20230811
Report Date20230913
Classification Date20230907
Address615 N 1st St
Pulaski, TN 38478-2403
United States
Recalling FirmAVKARE LLC
Initial Notification Letter
Unique Ingredient Identifier8ZYQ1474W7
Structured Product Labeling (SPL ID)eaedb2a2-ca74-27bc-e053-2995a90a9911
Structured Product Labeling (SPL Set ID)92fef2e0-f9f2-8b0f-e053-2995a90a096a
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.