The Food and Drug Administration (FDA) has ordered the recall of all batches of Bumetanide (Burinex) 500 micrograms-per-milliliter Solution for Injection (I.M./I.V.), a diuretic, after it was found to be tainted with formaldehyde.
“The affected product batches present safety risks and potential adverse health consequences due to the presence of formaldehyde,” the FDA said in an advisory.
Bumetanide is used in the treatment of oedema associated with heart failure and with renal and hepatic disorders.
It is given in high doses in the treatment of oliguria due to renal failure or insufficiency as well as for hypertension.
The product, manufactured by Cenexi in France, comes in 5 mL type I amber glass ampules containing 4 mL of solution (box of 5s).
The FDA has advised consumers not to purchase or use the affected product.
Suspected adverse reaction due to the use of the product should be reported immediately to the FDA, the agency said.
Distributors, hospitals, retailers and pharmacies that have the products have been instructed to discontinue its distribution, sale and use.