MB: Here's information about a recall of certain lots of Cleviprex injectable emulsion, an anti-hypertensive drug made by The Medicines Company.
AR: Vials in the recalled lots may contain particulate matter which has been found to be inert stainless steel particles. Although the company has not received any reports of adverse events, if these particles were to aggregate, or if larger particles were present, it's possible that patients could experience a reduction in capillary blood flow, mechanical damage to some tissues, or inflammatory reactions.
MB: Anyone who has vials from the affected lots should contact their wholesaler or distributor to arrange for return of the product. To get more information and to see the recalled lot numbers, go to our website or contact The Medicines Company at 1-888-977-6326.

标题
Cleviprex Recalled Due to Particulates (FDA)

视频介绍
FDA Patient Safety News - March, 2010 - Show #96
Here's information about a recall of certain lots of Cleviprex injectable emulsion, an anti-hypertensive drug made by The Medicines Company.

Speaker #1: Mark Barnett (MB), Assistant Director, Education & Communication, U.S. Food and Drug Administration

Speaker #2: Anita Rayner (AR), Associate Director, Policy & Communications, U.S. Food and Drug Administration