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3M Company - Health Care Business recalls 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1
Recalled November 7, 2018 · FDA recall Z-0368-2019 · 3M Company - Health Care Business
Hazard
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. · FDA Class II
Units
73 units (200 pack)
Sold at
US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
Description
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
Product
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.
Manufacturer(s)
3M Company - Health Care Business
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →