MANILA, Philippines - A drug used to treat heart failure has been recalled from the market, the Food and Drugs Administration (FDA) announced yesterday.
In an advisory, the FDA reported that IE Medica Inc. initiated a product recall of specific batches of dobutamine solution due to a change in the product’s appearance.
The FDA identified the recalled product as dobutamine (as hydrochloride) 12.5 milligram per milliliter (250 mg/20 ml) solution for injection (brand name Dobulon) with batch numbers DBI1301BC, DBI1302BC and DBI1303BC (DRP-3997).
According to the FDA, the batches were recalled after they turned dark yellow from a clear pale yellowish solution.
Dobutamine is used in the treatment of acute but potentially reversible heart failure, such as those that occur during cardiac surgery. It is also used in cases of congestive heart failure.