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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

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

Abbott Laboratories Recalls Lyophilized Prescription Antibiotics for Injection for use With ADD-Vantage Flexible Diluent Containers

PRODUCT
Lyophilized Rx antibiotics for injection packaged in single dose ADD-Vantage vials, for use only with ADD-Vantage Flexible Diluent Containers:
a) Cefazolin for Injection (lyophilized), Equivalent to 1-gram cefazolin, For I.V. Infusion only, Single dose ADD-Vantage Vial, NDC #0074-4732-03;
b) Tazicef, Ceftazidine for Injection, Equivalent to 2 grams ceftazidine, For I.V. Infusion Only, Single dose ADD-Vantage Vial.
NDC#0007-5091-01. Recall #D-169/170-9.

CODE
Lot numbers: a) 43-002-DA EXP 7/1/00; b) 43-003-DA EXP 7/1/00.

MANUFACTURER
SmithKline Beecham, Conshohocken, Pennsylvania.

RECALLED BY
Abbott Laboratories, Abbott Park, Illinois, by letter on March 26, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.QUANTITYa) 73,825 vials; b) 6,000 vials were distributed, with firm estimating that 1,500 vials of Cefazolin and 1,000 vials of Tazicef remaining on market at time of recall initiation.

REASON
Lack of assurance of sterility.

 

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.