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Last Updated: Apr 16, 2008 - 5:52:06 PM |
Cubicin (daptomycin for injection)
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Audience: Infectious disease healthcare professionals, hospital risk managers, and nursing service managers
[Posted 04/09/2008] Cubist Pharmaceuticals, Inc. informed healthcare
professionals that a potentially significant impurity,
2-mercaptobenzothiazole (MBT), has been isolated from reconstituted
Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured
by Cardinal Health, Inc. MBT is used in the manufacture of rubber and
has been reported to leach from rubber stoppers and syringe components
into medicinal products in the past. 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 are advised to discontinue using ReadyMED
elastomeric infusion pumps with Cubicin until the issue has been
addressed.
[April, 2008 - Letter - Cubist Pharmaceuticals, Inc.]
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