|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 10, 1998
Anzemet(R) Injection (Dolasetron Mesylate), 12.5 mg (20mg/mL), in 0.625 mL ampuls,
Rx anti-nauseant and anti-emetic agent. NDC #0088-1208-65.
Lot #73007091 EXP 5/99.
Ben Venue Laboratories, Bedford, Ohio. Contract Manufacture
Hoechst Marion Roussel, Inc., Cincinnati, Ohio, by letter on May 14, 1998.
Firm-initiated recall ongoing.
31,506 ampules were distributed; firm estimated that 30 percent of product (9,452
ampules) remained on market at time of recall initiation.
Precipitate formation (dolasetron sulfate crystals) due to inadequate ampule