Why it was recalled
Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Product description
Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478
Lot numbers, UPCs & expiration codes
Lot # P23025 Exp. 02/24/2025
Where it was sold
Affected product was distributed to nineteen (19) consignees within the united states.
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-1146-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 11, 2023
- FDA report date
- Sep 13, 2023
- Quantity
- 35,184 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE LLC
Original FDA data
Every field from FDA enforcement report D-1146-2023, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 92868
- Address
- 615 N 1st St
- Code information
- Lot # P23025 Exp. 02/24/2025
- Postal code
- 38478-2403
- Report date
- Sep 13, 2023
- Product type
- Drugs
- Recall number
- D-1146-2023
- Classification
- Class II
- Recalling firm
- AVKARE LLC
- Product quantity
- 35,184 tubes
- Termination date
- Apr 29, 2024
- Reason for recall
- Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478
- Distribution pattern
- Affected product was distributed to nineteen (19) consignees within the united states.
- Recall initiation date
- Aug 11, 2023
- Initial firm notification
- Letter
- Center classification date
- Sep 7, 2023