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April 12, 2001

Garamycin Ophthalmic Olution Gentamicin Sulfate Ophthalmic Solution and Gentak Sterile Solution Recalled

Kenilworth, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Schering Labortories has recalled certain Garamycin Ophthalmic Olution Gentamicin Sulfate Ophthalmic Solution and Gentak Sterile Solution because of chemical contamination- Dicyclohexyl Phthalate (DCHP) Product Label adhesive migration.

This is the first public notice of this Class III recall issued by FDA.

Garamycin Ophthalmic Olution Gentamicin Sulfate Ophthalmic Solution, USP) 3 GM/ML, 5 ML Bottles, NDC 0085-0899-05
Gentak Sterile Solution, DC 17478-283-0,PRIVATE LABEL for AKORN, INC., Buffalo Grove, Illinois.

Recall #D-161-1.

LOT NO.            EXP. DATE
0-AMS-2            10/2003
9-AMS-2            3/2002
9-AMS-3            6/2002
9-AMS-4        12/2002
8-AMS-5            5/2002
8-AMS-7            8/2001
8-AMS-9            8/2001
8-AMS-12        12/2001

9-AMS-1            2/2002
8-AMS-3            2/2001
8-AMS-4            5/2001
8-AMS-5            5/2001
8-AMS-8            8/2001
8-AMS-10        11/2001
8-AMS-11        11/2001

Schering Labortories, Kenilworth, NJ.

Manufacturer, by letters on 3/8/01 and telephone on 2/16/01. FDA(Firm)-initiated recall ongoing.


Approximately 389,089 units.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafetyAlerts subscribers April 12, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.