|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
May 26, 1998
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.
Lot numbers 170438 and 170449.
Fujisawa USA, Inc., Melrose Park, Illinois.
Fujisawa USA, Inc., Deerfield, Illinois, by letter dated April 30, 1998.
Firm-initiated recall ongoing.
3,455 vials were distributed; firm estimated that 25 percent remained on market at
time of recall initiation.
Incorrect volumes - Vials are labeled with graduation marks that do not indicate an