ICU Medical, Inc., a pure-play infusion therapy company, is recalling one lot of Aminosyn II, 15%, An Amino Acid Injection, Sulfite Free intravenous or IV solution to the hospital/user level, the U.S. Food and Drug Administration said in a statement.
The recall of 2,112 units of the amino acid injection was due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with other particles.
The recall involves amino acid injection sulfite-free that comes in pharmacy bulk package 2-liter flexible container with lot number 4989094 and expiration date of 01-Apr-2022.
The affected product contains a Hospira NDC number and a Hospira label as ICU Medical acquired this product from Hospira, a Pfizer co. The affected product lot is manufactured in the U.S. by ICU Medical in November 2020. The product was distributed nationwide by ICU Medical direct to customers and through medical distributors.
The San Clemente, California -based company became aware of the issue while inspecting retain samples as part of routine process.
According to the agency, the 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.
However, ICU Medical has not received reports of adverse events or illness related to this recall to date.
Hospitals and distributors that have the affected product are urged to stop using or further distribution and return to place of purchase.
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