The Medicines Company has expanded its December recall of clevidipine butyrate (Cleviprex), an injectable emulsion used to treat hypertension, after visible particulate matter was found in some vials.
According to the FDA, the following four additional lots have been recalled:
- 68-407-DJ, expiration August 2010;
- 68-408-DJ, expiration August 2011; and
- 71-101-DJ and 71-106-DJ, expiration November 2011.
The inert stainless steel particles could have the potential to reduce blood flow in the capillaries, cause damage to tissue or cause acute or chronic inflammatory reactions leading to ischemia or organ insufficiencies, according to the agency.
The FDA has asked that any adverse events be reported to its MedWatch Safety Information and Adverse Event Reporting Program.
Click here to view the additional 11 lots of drugs listed in the December 2009 recall.