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.
Check against the official notice below — it lists the full affected range.
3M Company is recalling 3M Fast Release Varnish, a prescription dental product in mint flavor, distributed in 200-pack units across California, Florida, Indiana, Nevada, Pennsylvania, Tennessee, Texas, and Washington. The product was recalled because a manufacturing error introduced extraneous material into the varnish, causing an unpleasant flavor. The affected product has Lot Number BFLSB and an expiration date of February 2020, with catalogue code 12158M.
The recall involves 73 units of the 200-pack product. The source document does not specify what consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
Reason for recall: Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. Distribution: US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA. Quantity: 73 units (200 pack) 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.