|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
April 14, 1999Glaxo Wellcome Inc. Recalls Fortaz ADD-Vantage Vials
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.
Lot numbers: B8419AA and B8769AF.
Glaxo Wellcome Inc., United Kingdom.
Glaxo Wellcome, Inc., Zebulon, North Carolina, by letter dated March 15, 1999.
Firm-initiated recall ongoing.
2,178 units of lot B8419AA and 669 units of lot B8769AF were distributed.
Lack of assurance of sterility (process validation failure-media simulation).