Why it was recalled
Microbial Contamination of Non-Sterile Product
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0247-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 17, 2018
- FDA report date
- Nov 14, 2018
- Quantity
- 994,756 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medline Industries Inc
Original FDA data
Every field from FDA enforcement report D-0247-2019, exactly as published.
Show all FDA fields
- City
- Northfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 81381
- Address
- Three Lakes Drive
- 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
- Postal code
- 60093
- Report date
- Nov 14, 2018
- Product type
- Drugs
- Recall number
- D-0247-2019
- Classification
- Class II
- Recalling firm
- Medline Industries Inc
- Product quantity
- 994,756 tubes
- Termination date
- Sep 4, 2020
- Reason for recall
- Microbial Contamination of Non-Sterile Product
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Sep 17, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 15, 2018