February 8, 2000Bausch 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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