D-0247-2019 Class II Terminated
FDA drug recall D-0247-2019 was initiated by Medline Industries Inc on Sep 17, 2018 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Product The recall status is terminated (terminated Sep 4, 2020). Affected quantity: 994,756 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 14, 2018
- Initiation Date
- Sep 17, 2018
- Termination Date
- Sep 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 994,756 tubes
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
Reason for Recall
Microbial Contamination of Non-Sterile Product
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0247-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026