FDA Drug recall D-0247-2019
SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (…
- FDA Drug
- Class II
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class II recall of SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (… by Medline Industries, citing microbial Contamination of Non-Sterile Product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0247-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-17 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
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
Microbial Contamination of Non-Sterile Product
Identifiers
| ndc | 53329-083-21 |
|---|---|
| ndc | 53329-083-92 |
| ndc | 53329-083-93 |
| ndc | 53329-083-94 |
| ndc | 53329-081-93 |
| code_info | 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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0247-2019%22
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