Ammonul Injection, manufactured by Ucyclyd Pharma, Inc, may be contaminated with particulate matter. In a letter, the company has informed hospital emergency doctors, nursing personnel and risk managers that the particulate contamination of Ammonul could affect the safety of the drug.
Ammonul is used to treat a condition caused by too much ammonia in the blood (hyperammonemia). Ammonia is formed from the breakdown of protein in the body. If the ammonia cannot be removed by the body, then a build up may cause serious unwanted effects. Ammonul works by causing less ammonia to be produced by the body.
Ucyclyd has informed healthcare providers of steps they can take to prevent adverse health affects caused by the particulate contamination of Ammonul. They have been instructed to use a MilIex” Durapore GV 33 mm Sterile Syringe Filter (0.22 /lm) during the admixture process when injecting Ammonul an IV bag. The company said testing has confirmed the removal of this specific particulate when using this filter to admix Ammonul.
Because the particulate matter may not be readily seen on visual inspection, the company says a filter must be employed in all cases regardless of whether particulate matter is seen in the vial.
As a precautionary measure, Ucyclyd said it will package MilIex” Durapore GV 33 mm Sterile Syringe Filters (0.22 /lm) with all shipments of Ammonul.
Adverse events related to use of Ammonul injection should be reported to the manufacturer by telephone 24 hours a day, 7 days a week, at 1-800-900-6389. Alternatively, case data may be relayed to the Food and Drug Administration’s (FDA) MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
More information on the Ammonul contamination issue can be obtained by visiting www.Ammonul.com.
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