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SafetyAlerts
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.

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

Recall #D-459-0.

CODE
Lot 0A1387

MANUFACTURER
Glaxo Wellcome, Inc., Zebulon, North Carolina.

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

DISTRIBUTION
Nationwide and Canada.

QUANTITY
36,463 units were distributed.

 
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Health Professional:

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During 2000 there were over
1050 products recalled in the United
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