October 24, 2000American Pharmaceutical Partners
Inc. Recalls Iopamidol-300
Park, IL (SafetyAlerts) - The Food
and Drug Administration (FDA) said today that American Pharmaceutical Partners Inc. is
recalling certain lots of its Iopamidol-300 because of a lack of efficacy.
This is the first public notice of
this Class III
recall issued by FDA.
Iopamidol-300 (Iopamidol Injection, USP) 61%, 150 mL in a 200 mL vial, Single
Dose, Rx for intravascular use for angiography throughout the cardiovascular system and
intravenous adult and pediatric contrast enhancement of computed tomographic head and body
Lot Numbers: 100119 EXP 02/02 and 100393 EXP 05/02.
American Pharmaceutical Partners, Inc., Melrose Park, Illinois.
Manufacturer, by letter dated September 21, 2000. Firm-initiated recall ongoing.
California and Virginia.
7,800 vials were distributed; firm estimated that 10 percent of product remained on market
at time of recall initiation.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.
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