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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 14, 1999

Glaxo Wellcome Inc. Recalls Fortaz ADD-Vantage Vials

PRODUCT
Fortaz ADD-Vantage Vials (Ceftazidime for injection) 1 g, Rx indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms for various diseases. Recall #D-168-9.

CODE
Lot numbers: B8419AA and B8769AF.

MANUFACTURER
Glaxo Wellcome Inc., United Kingdom.

RECALLED BY
Glaxo Wellcome, Inc., Zebulon, North Carolina, by letter dated March 15, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
2,178 units of lot B8419AA and 669 units of lot B8769AF were distributed.

REASON
Lack of assurance of sterility (process validation failure-media simulation).

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.