FDA MedWatch - Aminosyn II 15%, An Amino Acid Injection, Sulfite Free IV Solution by ICU Medical:

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TOPIC: Aminosyn II 15%, an Amino Acid Injection, Sulfite Free IV Solution by ICU Medical: Recall - Due to the Presence of Particulate Matter

AUDIENCE: Patient, Risk Manager, Pharmacy

ISSUE:  ICU Medical is recalling one lot of Aminosyn II, 15%, an amino acid injection, sulfite free intravenous (IV) solution due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with other particles. ICU Medical became aware of this issue while inspecting retain samples as part of routine process.

Administration of a drug product that contains particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death.

To date, ICU Medical has not received reports of adverse events or illness related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The product being recalled, Aminosyn II, sulfite-free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. 

Aminosyn II is also indicated for central vein infusion to prevent or reverse excreting more nitrogen than is being taken in in patients where the intestinal tract, by the oral, surgical opening into the stomach for the introduction of food or surgical procedure for a feeding tube routes cannot or should not be used and gastrointestinal absorption of protein is impaired.

RECOMMENDATIONS: 

• Hospitals/distributors that have product that is being recalled should stop use/further distribution and return to place of purchase.
• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.