Bristol-Myers Squibb ($BMY) in April quit making injected Coumadin, the form used in the rare cases when patients can't take the oral formulation. But there is still product in the market and and the company is having to recall some of it.
The drugmaker announced the recall Monday, followed the next day by the FDA. Bristol-Myers said that it is recalling 6 lots of the blood thinner after a small number of unreleased samples were found to have visible particulate. There have been no reports of problems and it said the risk was low but acknowledged there is a health risk for anyone injected with particulate.
The drugmaker made a point of saying the recall does not affect Coumadin tablets, by far the more widely used version of the blood thinner. In fact, BMS spokesman Ken Dominski said in an email Wednesday that the "IV formulation represents .02% of the total use of Coumadin in the U.S." Because of the limited use, BMS decided to stop making the injected form. He said there is no connection between the recall and the decision to stop making the injected form and the recall.
This is the second recall for BMS in the last 5 months. In February it began a recall of about 39,000 bottles of the HIV medication Atripla it produces with Gilead Sciences ($GILD). The Atripla tablets were recalled after red silicone rubber was found in some of them.
- here's BMS release