Cleviprex Recall Expanded

A recall of <"">Cleviprex injectable emulsion by The Medicines Company has been expanded. The recall, first announced last December, was issued due to the potential presence of visible particulate matter which has been observed in some vials.

According to the recall notice, the particulate matter observed in the Cleviprex injectable emulsion is comprised of sub-visible inert stainless steel particles of around 2.5 microns. Particles could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.

The four additional lots included in the recall are:

• 68-407-DJ, Exp. 08/2010;
• 68-408-DJ, Exp. 08/2011;
• 71-101-DJ, Exp, and 71-106-DJ, Exp. 11/2011.

The previously recalled lots were:

• 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.

Anyone with inventory from the affected lots of Cleviprex should arrange for its return through their pharmaceutical wholesaler/distributor.

For medical inquiries, adverse event reporting or quality issues related to Cleviprex, please contact The Medicines Company Medical Information at 1-888-977-6326 Monday to Friday 8:00am-5:30pm EST or

Any adverse reactions associated with the use of Cleviprex may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at

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