FDA Recall
Open, Classified
Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Recall: Z-0661-2020
·
Initiated October 30, 2019
Recall
- Recall Number
- Z-0661-2020
- Event Number
- 84249
- Firm
- Young Dental Manufacturing Co, LLC
- FEI Number
- 1941138
- Product Code
- LBH
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- October 30, 2019
- Address
- 13705 Shoreline Ct E, Earth City, MO, 63045-1202
Description
Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Reason
Product shelf life may be shorter than that indicated on the label.
Action
Notification by letter to be made to customer via certified mail. Customers are instructed to return or scrap the affected product. Multiple attempts will be made to contact customers. Returned product will be destroyed. For recall inquiries, contact 224-622-7191.
Distribution
US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.
Quantity
Batch 84702 - 6500 units; Batch 72766 - 6500 units