Recall Z-0661-2020
Young Dental Manufacturing Co, LLC · initiated October 30, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Batch 84702; Batch 72766
Reason for recall
Product shelf life may be shorter than that indicated on the label.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0661-2020
- Initiated
- October 30, 2019
- Product code
- LBH – Varnish, Cavity
- Quantity
- Batch 84702 - 6500 units; Batch 72766 - 6500 units
- Distribution
- US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.
- Recalling firm
- Young Dental Manufacturing Co, LLC, Earth City, MO