Leached Impurity Found in Cubicin Stored in Cardinal Health’s ReadyMED Pumps

May 8, 2008
BioPharm International Editors

Cubist Pharmaceuticals, Inc. (Lexington, MA) informed healthcare professionals on April 4 that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. (Dublin, OH).

Cubist Pharmaceuticals, Inc. (Lexington, MA) informed healthcare professionals on April 4 that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. (Dublin, OH). MBT is used in the manufacture of rubber and has been reported to leach from rubber stoppers and syringe components into medicinal products. Cutaneous exposure to MBT has been associated with dermal sensitization, and chronic administration of MBT to laboratory rodents has been associated with an increased risk of certain tumors. No MBT has been identified in reconstituted Cubicin in other standard types of infusion systems that have been tested. Healthcare professionals have been advised to discontinue using ReadyMED elastomeric infusion pumps with Cubicin until the issue has been addressed.

Letter from Cubist (PDF)

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