Bulletin
Sodium Fluoride Chewable Tablets
13 October 2009
Products Affected - Description
Sodium fluoride 0.5 mg chewable tablets, 1000-count (NDC 52152-0127-05), Actavis – discontinued
Sodium fluoride 1 mg chewable tablets, 1000-count (NDC 52152-0128-05), Actavis – discontinued
Ethedent 0.25 mg chewable tablets, 120-count (NDC 58177-0432-40), Ethex - discontinued
Ethedent 0.5 mg chewable tablets, 120-count (NDC 58177-0433-40), Ethex - discontinued
Ethedent 0.5 mg chewable tablets, 1000-count (NDC 58177-0433-09), Ethex - discontinued
Ethedent 1 mg chewable tablets, 120-count (NDC 58177-0434-40), Ethex - discontinued
Ethedent 1 mg chewable tablets, 1000-count (NDC 58177-0434-09), Ethex - discontinued
Luride 0.25 mg chewable tablets, 120-count (NDC 00126-0186-21), Colgate – discontinued
Luride 0.5 mg chewable tablets, 120-count (NDC 00126-0014-21), Colgate – discontinued
Luride 1 mg chewable tablets, 120-count (NDC 00126-0006-21), Colgate – discontinued
Pharmaflur 1 mg chewable tablets, 120-count (NDC 00813-0067-12), Pharmics – discontinued
Pharmaflur 1.1 mg chewable tablets, 120-count (NDC 00813-0065-12), Pharmics – discontinued
Pharmaflur 2.2 mg chewable tablets, 120-count (NDC 00813-0066-12), Pharmics – discontinued
Sodium fluoride 2.2 mg chewable tablets, 100 count (NDC 58223-0676-01), Kirkman – discontinued
Sodium fluoride 2.2 mg chewable tablets, 1000 count (NDC 58223-0673-04), Kirkman – discontinued
Reason for the Shortage
- Actavis has discontinued their fluoride chewable tablets due to manufacturing problems.
- Pharmascience states Fluor-A-Day chewable tablets are on back order due to increased demand.
- Colgate has discontinued all its Luride chewable tablets. The company would not provide a reason for the discontinuation.
- Pharmics has discontinued Pharmaflur chewable tablets for unknown reasons.
- Ethex has discontinued Ethedent chewable tablets for unknown reasons.
- Kirkman had discontinued their previous 2.2 mg tablets due to product formulation issues. The company recently introduced a new 2.2 mg tablet presentation.
Estimated Resupply Dates
- Pharmascience has all of their Fluor-A-Day chewable tablets available including the 0.25 mg tablets (NDC 51817-0602-16), 0.5 mg tablets (NDC 51817-0611-16) and the 1 mg tablets (NDC 51817-0622-16).
- Kirkman has available sodium fluoride 0.55 mg chewable tablets in 100-count (NDC 58223-0675-01) and 1000-count (NDC 58223-0675-04) bottles and 1.1 mg chewable tablets in 100-count (NDC 58223-0674-01) and 1000-count (NDC 58223-0674-04) bottles. Kirkman also has a new 2.2 mg tablet in 100-count bottle size available (NDC 58223-0677-01).
- Fluoritab is available as 0.5 mg chewable tablets in 100-count (NDC 00288-1106-01), 1000-count (NDC 00288-1106-10), and 5000-count (NDC 00288-1106-02) bottles; and 1 mg chewable tablets in 100-count (NDC 00288-2203-01), 1000-count (NDC 00288-2203-10), and 5000-count (NDC 00288-2203-02) bottles.
- River’s Edge Pharma has available Renaf 1 mg chewable tablets in 120 count (NDC 68032-0384-12) and 1000 count (NDC 68032-0384-00) bottles, 0.5 mg chewable tablets in 120 count (NDC 68032-0383-12) and 1000 count (NDC 68032-0383-00) bottles, and 0.25 mg chewable tablets in 120 count bottles (NDC 68032-0382-12).
Related Shortages
Updated
October 13, 2009; August 19, 2009; June 30, 2009; May 29, 2009; April 13, 2009; March 12, 2009; March 2, 2009; February 6, 2009; January 8, 2009; December 22, 2008; November 19, 2008; October 22, 2008; September 29, 2008, University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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