February 8, 2000American 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
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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