FDAFDA · Food and drugs·Recall number Z-0661-2020
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.
Published December 18, 2019 · Recall initiated: October 30, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product shelf life may be shorter than that indicated on the label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Young Dental Manufacturing Co, LLC
- Distributor
- US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.
- Lot
- Batch 84702; Batch 72766
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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