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February 8, 2000

Bausch and Lomb Pharmaceuticals Recalls Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution

Tampa, FL (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Bausch and Lomb Pharmaceuticals is recalling Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution because one unit was found to contain Hydrocortisone Otic Suspension not Hydrocortisone Solution as labeled.

The recalled Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution, USP, Rx, 3.5mg/10,000 units/10mg (1%), 10 mL with sterile dropper was distributed nationwide

According to FDA, 45,808 units were distributed and can be identified by the Lot Number #205101 EXP 4/01.

This ongoing Class III recall was initiated by Bausch and Lomb Pharmaceuticals by letter December 7, 1999.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall  #D-212-0

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Health Professional:

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During 2000 there were over
1050 products recalled in the United
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