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October 24, 2000

American Pharmaceutical Partners Inc. Recalls Iopamidol-300

Melrose 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 imaging.
NDC #63323-803-60.

Recall #D-001-1.

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.

Selected Recent Recalls

Health Professional:

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

How many did you hear about?

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