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Cleviprex (clevidipine butyrate): Recall
Audience: Pharmacists, risk managers
[UPDATE] The December 2009 recall has been expanded to include four additional lots with the lot numbers and expiration dates noted in the firm press release of March 17, 2010.
[Posted 12/17/2009] The Medicines Company and FDA notified healthcare professionals of a nationwide recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion, indicated for treatment of hypertension, due to the potential presence of particulate matter found to be inert stainless steel particles. If the particles were to aggregate, or if larger particles were present, then they 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.
See the company press release for information on specific lots affected by this recall.
Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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