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
D-0598-2021
Product summary
- Firm
- Accupac, Inc.
- Event
- Event 87944
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,261 cases/24 tubes per case = 54,264 tubes
- Official record key
drug-enforcement:D-0598-2021
Official wording
Reason: Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Code information: LOT 0317M107 with expiry Oct 12 2022 LOT1075M107 with expiry Feb 16 2023
Distribution pattern: Naitonwide in the US and Puerto Rico.
Derived failure modes
-
Labeling or packaging
incorrectly labeled