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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
May 26, 1998

PRODUCT
Sterile Vancomycin Hydrochloride, USP, lyophilized, 10g/100mL vial, pharmacy bulk package, not for direct infusion, Rx, lyophilized powder for preparing intravenous infusions for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci. NDC #0469-3140-61.

Recall #D-144-8.

CODE
Lot numbers 170438 and 170449.

MANUFACTURER
Fujisawa USA, Inc., Melrose Park, Illinois.

RECALLED BY
Fujisawa USA, Inc., Deerfield, Illinois, by letter dated April 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
3,455 vials were distributed; firm estimated that 25 percent remained on market at time of recall initiation.

REASON
Incorrect volumes - Vials are labeled with graduation marks that do not indicate an accurate volume.

 

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.