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Cleviprex FDA Alerts

The FDA Alert(s) below may be specifically about Cleviprex or relate to a group or class of drugs which include Cleviprex (clevidipine).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for clevidipine

Cleviprex (clevidipine butyrate): Recall

Mar 17, 2010

Audience: Pharmacists, risk managers

 

The 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.

Cleviprex (clevidipine butyrate): Recall

Dec 17, 2009

Audience: Pharmacists, risk managers

 

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.

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