PlainRecalls
FDA Drug Moderate Class II Terminated

Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v fluoride ion), Net Wt. 4.1 oz.,116 g, , Distr by Native, San Francisco, CA 94111 NDC: 69423-903-41, UPC 0 37000 28803 9

Reported: June 2, 2021 Initiated: May 13, 2021 #D-0598-2021

Product Description

Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v fluoride ion), Net Wt. 4.1 oz.,116 g, , Distr by Native, San Francisco, CA 94111 NDC: 69423-903-41, UPC 0 37000 28803 9

Reason for Recall

Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride

Details

Recalling Firm
Accupac, Inc.
Units Affected
2,261 cases/24 tubes per case = 54,264 tubes
Distribution
Naitonwide in the US and Puerto Rico.
Location
Mainland, PA

Frequently Asked Questions

What product was recalled?
Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v fluoride ion), Net Wt. 4.1 oz.,116 g, , Distr by Native, San Francisco, CA 94111 NDC: 69423-903-41, UPC 0 37000 28803 9. Recalled by Accupac, Inc.. Units affected: 2,261 cases/24 tubes per case = 54,264 tubes.
Why was this product recalled?
Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Which agency issued this recall?
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0598-2021.