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December 28, 1999

Bausch and Lomb Fluocinolone Acetonide Topical Solution Recalled

Tampa, FL (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Bausch and Lomb Pharmaceuticals is recalling Fluocinolone Acetonide Topical Solution because of subpotency.

This ongoing Class III recall was initiated by the company by letter on November 5, 1999.  This is the first public notice issued by the FDA.

The Recalled Fluocinolone Acetonide Topical Solution, USP, 0.01%, in 20 and 60 mL bottles is a non-sterile, topical solution used to treat corticosteroid-responsive dermatoses.  All lot numbers within Expiration date are subject to the recall.  Over 219,000 units were distributed Nationwide.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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