Particulate Matter Found in Ammonul Injection
Ucyclyd Pharma, Inc. has informed the U.S. Federal Food and Drug Administration (FDA) of particulate matter detected in their product Ammonul® (sodium phenylacetate and sodium benzoate) Injection. Until further notice, the manufacturer will supply Millex® Durapore GV 33 mm sterile syringe filters (0.22 µm) with the product, and advises clinicians to use the filters during the admixture process when injecting Ammonul into the 10-percent dextrose IV bag.
Ammonul Injection 10%/10% is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate used for treatment of acute hyperammonemia in urea cycle disorders.
The FDA released an alert Sept. 23 and asks that you report adverse events related to Ammonul Injection by phone (800) FDA-1088, fascimile (800) FDA-0178 or the Internet www.fda.gov/medwatch. You can also contact the manufacturer at (800) 900-6389.