Why it was recalled
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
Lot numbers, UPCs & expiration codes
LOT 0317M107 with expiry Oct 12 2022 LOT1075M107 with expiry Feb 16 2023
Where it was sold
Naitonwide in the US and Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0598-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 13, 2021
- FDA report date
- Jun 2, 2021
- Quantity
- 2,261 cases/24 tubes per case = 54,264 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accupac, Inc.
Original FDA data
Every field from FDA enforcement report D-0598-2021, exactly as published.
Show all FDA fields
- City
- Mainland
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 87944
- Address
- 1501 Industrial Boulevard
- Code information
- LOT 0317M107 with expiry Oct 12 2022 LOT1075M107 with expiry Feb 16 2023
- Postal code
- 19451
- Report date
- Jun 2, 2021
- Product type
- Drugs
- Recall number
- D-0598-2021
- Classification
- Class II
- Recalling firm
- Accupac, Inc.
- Product quantity
- 2,261 cases/24 tubes per case = 54,264 tubes
- Termination date
- Aug 11, 2021
- Reason for recall
- Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- May 13, 2021
- Initial firm notification
- Center classification date
- May 26, 2021