Recalls / Class II
Class IID-0247-2019
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
- Brand name
- Sparklefresh
- Generic name
- Sodium Monofluorophosphate
- Active ingredient
- Sodium Monofluorophosphate
- Route
- Dental
- NDC
- 53329-083
- FDA application
- M021
- Affected lot / 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
Why it was recalled
Microbial Contamination of Non-Sterile Product
Recalling firm
- Firm
- Medline Industries Inc
- Manufacturer
- Medline Industries, LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Three Lakes Drive, Northfield, Illinois 60093
Distribution
- Quantity
- 994,756 tubes
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2018-09-17
- FDA classified
- 2018-11-15
- Posted by FDA
- 2018-11-14
- Terminated
- 2020-09-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0247-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.