March 8, 2000AstraZeneca
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
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.
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