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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
June 10, 1998

PRODUCT
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.

Recall #D-169-8.

CODE
Lot #73007091 EXP 5/99.

MANUFACTURER
Ben Venue Laboratories, Bedford, Ohio. Contract Manufacture

RECALLED BY
Hoechst Marion Roussel, Inc., Cincinnati, Ohio, by letter on May 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
31,506 ampules were distributed; firm estimated that 30 percent of product (9,452 ampules) remained on market at time of recall initiation.

REASON
Precipitate formation (dolasetron sulfate crystals) due to inadequate ampule washing.

 

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.