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SafetyAlerts
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.

PRODUCT
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.

CODE
Lot Numbers: 100119 EXP 02/02 and 100393 EXP 05/02.

MANUFACTURER
American Pharmaceutical Partners, Inc., Melrose Park, Illinois.

RECALLED BY
Manufacturer, by letter dated September 21, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
California and Virginia.

QUANTITY
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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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.