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March 8, 2000

AstraZeneca Recalls Seroquel (Quetiapine Fumarate)

Wilmington, DE (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that AstraZeneca is recalling certain Seroquel (Quetiapine Fumarate) 25 mg Tablets because some tablets may have become wet during packaging.

According to the FDA, over 26,000 bottles were distributed nationwide.

The recalled oral prescription medication (NDC # 0310-0275-10), for the management of the manifestations of psychotic disorders, including schizophrenia was sold in 100-tablet bottles - 12 bottles per case.  The recalled product bears the code of 4750B EXP 10/01.

This ongoing Class III recall was initiated by AstraZeneca by letter February 11, 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-225-0

Notice of this product warning was sent via email to SafeMail subscribers March 8, 2000.

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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