FDAFDA · Food and drugs·Recall number Z-0368-2019
3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth.
Published November 7, 2018 · Recall initiated: July 6, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- 3M Company - Health Care Business
- Distributor
- US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
- Lot
- Catalogue Code: 12158M, 3M ID Number 70-2014-0568-8, Lot Number BFLSB, Lot # BFLSB, Expiration Date 2020-02, GTIN (consumer primary carton) 30605861060661, GTIN (shipper) 50605861060665
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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