December 28, 1999Bausch 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
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
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