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Particulate Matter Prompts Cleviprex Recall

Dec 17, 2009 | Parker Waichman LLP

Cleviprex  is being recalled today by The Medicines Company because it may be tainted with particulate matter. 

According to the Food & Drug Administration (FDA), the particulate matter comprises sub-visible inert stainless steel particles of around 2.5 microns. When this matter is present in low numbers, as is the case in this recall, particles of this size are not known to lead to a health hazard. If these sub-visible particles were to combine, or if larger particles are present, they could become visible and could potentially reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. A reduced blood supply to tissues could lead to ischemia or organ insufficiency in the brain, kidney, liver, heart, or lungs.

The affected Cleviprex lots are:

•    61-978-DW, 61-979-DW, and 61-980-DW: Exp. 01/2010;
•    68-404-DJ, 68-405-DJ, and 68-406-DJ: Exp. 08/2010;
•    69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ: Exp 03/2011;
•    64-453-DJ: Exp. 04/2011

No other lots are affected by this recall.

To date, the Medicines Company has not received any product complaints or reports of adverse events related to this issue.

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