March 21, 2001Voluntary Recall of Rabies
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.
LOT NUMBERS / EXPIRATION DATE:
261011 9/2001 or 9/2003
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
P. O. Box 1630
Marburg D-35006, Germany.
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