Accupac, Inc.: Drug Recall
Recall #D-0598-2021 · 05/13/2021
Class II: Risk
Recall Details
- Recall Number
- D-0598-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Accupac, Inc.
- Status
- Terminated
- Date Initiated
- 05/13/2021
- Location
- Mainland, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,261 cases/24 tubes per case = 54,264 tubes
Reason for Recall
Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
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
Distribution Pattern
Naitonwide in the US and Puerto Rico.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.