September 14, 1999
Floxin Otic Sterile (oxfloxacin otic solution)
Recalled by Daiichi Pharmaceutical Corp.
Montvale, NJ (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Daiichi Pharmaceutical Corp. is recalling Floxin
Otic Sterile (oxfloxacin otic solution) because of leakage and lack of assurance of
sterility (indentation at bottle seal).
Floxin Otic Sterile (oxfloxacin otic solution), 0.3%,
5 Ml, Rx sterile anti-bacterial solution for use in the treatment of certain types of
otitis media (ear infections).NDC #63395-101-05.
Recall #D-419-9. Class II
All lot numbers (34 total) shipped prior to October 11, 1998: (Lot #: and
Parkedale Pharmaceuticals, Inc., Rochester, Michigan.
Daiichi Pharmaceutical Corporation, Montvale, New Jersey, by telephone and Federal
Express on June 14, 1999, followed by fax on June 14-16, 1999. Firm-initiated recall
637,210 units were distributed.
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