Drug 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
D-0247-2019
Product summary
- Event
- Event 81381
- Status
- Terminated
- Classification
- Class II
- Quantity
- 994,756 tubes
- Official record key
drug-enforcement:D-0247-2019
Official wording
Reason: Microbial Contamination of Non-Sterile Product
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
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Microbial contamination
Microbial Contamination