medical Class II Updated 2018-11-07

3M Company - Health Care Business recalls 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx

Recalled 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.

Hazard / Issue

Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.

Issued by

FDA

Affected States: CA, FL, IN, NV, PA, TN, TX, WA

Lot/Code Info: 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

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