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September 20, 2000

Glaxo Recalling Leukeran(r)

Zebulon, NC (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Glaxo Wellcome, Inc. is recalling its Leukeran(r) (chlorambucil) Tablets because of impurity specification failure (stability).

This is the first public notice of this Class III recall issued by FDA.

Leukeran(r) (chlorambucil) Tablets, 2 mg, in 50-count bottles, Rx. NDC 0173-0635-35.

Recall #D-459-0.

Lot 0A1387

Glaxo Wellcome, Inc., Zebulon, North Carolina.

Manufacturer, by letter on August 21, 2000. Firm-initiated recall ongoing.

Nationwide and Canada.

36,463 units were distributed.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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