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Safety Alerts
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   Exp. Date)
02228P 06/19/1999
00228P 01/22/2000
02328P 06/24/1999
00328P 01/29/2000
02428P 06/26/1999
00428P 02/05/2000
01307P 09/23/1999
00238P 02/12/2000
01407P 09/30/1999
00338P 02/17/2000
01507P 09/30/1999
00538P 03/09/2000
01607P 10/02/1999
00348P 03/19/2000
007N7P 10/08/1999
00158P 03/30/2000
008N7P 10/14/1999
00258P 04/01/2000
009N7P 10/16/1999
00658P 04/15/2000
010N7P 10/20/1999
00168P 04/17/2000
011N7P 10/22/1999
00268P 04/19/2000
00418P 12/01/1999
00178P 05/30/2000
00518P 12/01/1999
01278P 06/25/2000
00618P 12/09/1999
00188P 07/30/2000
00718P 12/11/1999
00288P 08/02/2000
00128P 01/20/2000
00388P 08/04/2000.

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 ongoing.


637,210 units were distributed.

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.