September 20, 2000Glaxo Recalling Leukeran(r)
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
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.
Safety Alerts compiles
comprehensive safety recall information for the United States. SafeMail is a free email
service to warn consumers of faulty products and contaminated foods. For complete
information regarding current recalls, past recalls and timely product warning
notification visit: www.safetyalerts.com.