Voluntary Recall of Rabies Vaccine, (RabAvert)

DATE RECALL INITIATED:

March 16, 2001

LOT NUMBERS / EXPIRATION DATES:

261011 09/2001 or 9/2003
273011 1/2004

RECALLING FIRM (Distributor):

Chiron Corporation
4560 Horton St.,
Emeryville, CA 94608

MANUFACTURER:

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

REASON:

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. The recall was initiated because the firm can not assure that the products are sterile. Customers were asked to discontinue use of the product and return all stock.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.