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Examples
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Sanofi SA's Genzyme unit has recalled one batch of leukemia drug Fludara due to concerns about its sterility—the latest in a series of supply and quality issues arising from troubles at a contract manufacturer.
Sanofi Unit Recalls One Lot of Leukemia Drug Peter Loftus 2012
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Fludara was being manufactured for Genzyme at a Ben Venue Laboratories plant in Ohio where U.S. and European health regulators have identified contamination-related deficiencies.
Sanofi Unit Recalls One Lot of Leukemia Drug Peter Loftus 2012
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Sanofi said no Fludara lots have been manufactured by Ben Venue for U.S. distribution since June 2010.
Sanofi Unit Recalls One Lot of Leukemia Drug Peter Loftus 2012
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According to a notice posted online Wednesday by the Food and Drug Administration, Genzyme sent letters to customers Jan. 31 and Feb. 1, alerting them that one lot of Fludara, comprising 9,380 vials, was being recalled.
Sanofi Unit Recalls One Lot of Leukemia Drug Peter Loftus 2012
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Fludara is a chemotherapy approved to treat B-cell chronic lymphocytic leukemia.
Sanofi Unit Recalls One Lot of Leukemia Drug Peter Loftus 2012
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Genzyme, in raising doubts about two of Mr. Icahn's nominees, cites its blood cancer treatments Campath and Fludara, which compete with Rituxan, sold by Biogen and Roche.
Board Ties Begin to Trip Up Companies Miguel Bustillo 2010
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Genzyme, in raising doubts about two of Mr. Icahn's nominees, cites its blood cancer treatments Campath and Fludara, which compete with Rituxan, sold by Biogen and Roche.
Board Ties Begin to Trip Up Companies Miguel Bustillo 2010
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Genzyme, in raising doubts about two of Mr. Icahn's nominees, cites its blood cancer treatments Campath and Fludara, which compete with Rituxan, sold by Biogen and Roche.
Board Ties Begin to Trip Up Companies Miguel Bustillo 2010
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As part of the deal, Genzyme is also acquiring two other cancer drugs from Bayer, named Fludara and Leukine.
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On January 31, Sanofi's Genzyme unit informed the U.S. Food and Drug Administration that it was notifying customers of a limited recall of a specific lot of Fludara, also known as fludarabine phosphate.
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