More Cleviprex Recalled Over Particulate MatterMar 18, 2010 | Parker Waichman LLP
The Medicines Company has expanded a recall of Cleviprex injectable emulsion it announced this past December. Four more lots are now included. They 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.
The recall 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.
Anyone with inventory from the affected lots of Cleviprex should arrange for its return through their pharmaceutical wholesaler/distributor.