FDA recall D-0598-2021

Accupac, Inc. · Class II · drug

Product

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

Distribution

Naitonwide in the US and Puerto Rico.

Key facts

Status
Terminated
Initiation date
2021-05-13
Report date
2021-06-02
Termination date
2021-08-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mainland, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0598-2021