Federal health regulators are warning doctors about 11 recalled lots of an intravenous hypertension drug made by the Medicines Co. that are contaminated with bits of steel.
The New Jersey based company recalled the affected lots of Cleviprex on Wednesday, December 16, 2009, after detecting tiny particles of stainless steel during a routine inspection.
The Food and Drug Administration said in a notice Thursday that the particles could potentially disrupt blood flow to the brain, kidney, liver heart and lungs.
Cleviprex is used to lower excessively high blood pressure in patients who cannot take pills. It is distributed to doctors for injection in patients who are undergoing surgery.
In a letter to health care professionals, the company recommends doctors inspect vials of the drug for possible contamination before using them. Medicines Co. says it has not received any reports of health problems connected with the issue.