Chiron in 2001 - Voluntary Recall of Rabies Vaccine, (RabAvert)

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http://www.fda.gov/cber/recalls/chirab031601.htm

Voluntary Recall of Rabies Vaccine, (RabAvert)

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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.

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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.

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Sheri Nakken, R.N., MA, Classical Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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OR LEGAL ADVICE. THE DECISION TO VACCINATE IS YOURS AND YOURS ALONE.

******

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