AVKARE LLC: Drug Recall
Recall #D-1146-2023 · 08/11/2023
Class II: Risk
Recall Details
- Recall Number
- D-1146-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- AVKARE LLC
- Status
- Terminated
- Date Initiated
- 08/11/2023
- Location
- Pulaski, TN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,184 tubes
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
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.
Other Recalls by AVKARE LLC
- Class II: Risk 08/11/2023
- Class III: Low Risk 06/13/2023
- Class II: Risk 12/22/2022
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.