April 12, 2001Garamycin Ophthalmic Olution
Gentamicin Sulfate Ophthalmic Solution and Gentak Sterile Solution Recalled
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
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,
LOT NO. EXP. DATE
Schering Labortories, Kenilworth, NJ.
Manufacturer, by letters on 3/8/01 and telephone on 2/16/01. FDA(Firm)-initiated recall
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.