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…
- Recall date
- July 6, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0368-2019
- FDA classification
- Class II
- Brand / firm
- 3M Company - Health Care Business
- Sold / distributed
- US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
Why it was recalled
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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