D-0598-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 2, 2021
- Initiation Date
- May 13, 2021
- Termination Date
- August 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,261 cases/24 tubes per case = 54,264 tubes
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
Distribution Pattern
Naitonwide in the US and Puerto Rico.
Code Information
LOT 0317M107 with expiry Oct 12 2022 LOT1075M107 with expiry Feb 16 2023