Sparklefresh Paste, Dentifrice
FDA Recall NDC 53329-083
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 Sparklefresh (NDC 53329-083). A significant event, classified as Class II, was initiated on Sep 17, 2018 by Medline Industries, Lp. The reported reason for this action was: "Microbial Contamination of Non-Sterile Product"
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
September 2018 Class II Recall: Microbial Contamination of Non-Sterile Product
Recall Number
Class II Terminated
Microbial Contamination of Non-Sterile Product
Sep 17, 2018
Nov 14, 2018
994,756 tubes
Recall Profile & Regulatory Data
Event ID
81381
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Medline Industries Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Puerto Rico
Termination Date
Sep 04, 2020
Product Description
SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA
Batch or Lot Expiration Information
Lot# a) Lot 102920C, exp 10/29/2020 and 111220C, exp 11/11/2020; b) 111620D, exp 11/16/2020; c) 111420D, exp 11/14/2020; d) 111720C, exp 11/17/2020
Affected Packages Involved in this Recall
53329-083-21Product
53329-083-92Product
53329-083-93Product
53329-083-94Product
53329-081-93Product
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.
