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SafetyAlerts
February 8, 2000

American Pharmaceutical Partners Recall Adenoscan (r) Adenosine

Melrose Park, IL (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that American Pharmaceutical Partners, Inc (APP) is recalling Adenoscan (r) Adenosine because of chipped and leaking vials and the possible presence of glass particles in vials.

The recalled Adenoscan (r) Adenosine (90 mg/30 mL), NDC #0469-0871- was distributed in 30 mL single-dose vial and is used for intravenous infusion only. The prescription intravenous infusion nucleoside vasolidator is used as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.

According to FDA, 275,151 vials were distributed nationwide.  FDA estimated that 100,000 vials remained on the market at time of recall initiation.  The recalled vials can be identified by the Lot Numbers 190244, 190249, 190258, 190613, 190665 and 190677.

This ongoing Class II recall was initiated by APP by telephone on January 11, 2000, followed by letter dated January 13, 2000.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #D-208-0

 
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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.