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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

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

Glaxo Wellcome Inc. Recalls Myleran Tablets

PRODUCT
Myleran Tablets (busulfan), 2 mg, in 25 tablet bottles, indicated for the palliative treatment of chronic myelogenous leukemia. Recall #D-167-9.

CODE
Lot #8G1422.

MANUFACTURER
Glaxo Wellcome Inc., Zebulon, North Carolina.

RECALLED BY
Manufacturer, by letter on February 24, 1999.

DISTRIBUTION
Nationwide.

QUANTITY
8,426 units were shipped.

REASON
Subpotent (stability).

 

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.