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
Reported: November 14, 2018 Initiated: September 17, 2018 #D-0247-2019
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
Details
- Recalling Firm
- Medline Industries Inc
- Units Affected
- 994,756 tubes
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Medline Industries Inc. Units affected: 994,756 tubes.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Product
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 14, 2018. Severity: Moderate. Recall number: D-0247-2019.
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