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March 21, 2001

Voluntary Recall of Rabies Vaccine, RabAvert

Marburg, Germany (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Chiron Behring GmbH & Co is recalling certain lot numbers of its RabAvert rabies vaccine.  The recall was initiated because the firm can not assure that the products are sterile.

261011    9/2001 or 9/2003
273011    1/2004

Chiron Corporation received seven customer complaints of broken and/or cracked vials following shipment of these RabAvert lots. An internal inspection of remaining inventory revealed that the bottom of the vial of diluent (sterile water for injection) was placed in line with the bottom of the product vial (lyophilized rabies vaccine). For those lots noted above, the investigation confirmed that bottom-to-bottom positioning of the two vials may have caused the breakage and/or cracking of the vials. Customers were asked to discontinue use of the product and return all stock.

Chiron Behring GmbH & Co
Emil-Von-Behring Strasse
P. O. Box 1630
Marburg D-35006, Germany.

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