Recall report: Amino acid IV pulled after hair, other foreign substances found in batch
A California infusion therapy company is voluntarily recalling one lot of an amino acid injection made by Pfizer spinout company Hospira after reports of fibers, hair and other particles of foreign materials were found in the solution.
ICU Medical recalled 2,112 units of Aminosyn II, 15%, after it became aware of the issue while inspecting samples as part of a routine process, the FDA said. The administration of a drug with particulates that do not belong can cause side effects ranging from inflammation at the point of injection to blood clots. So far, ICU Medical hasn’t reported any side effects or illnesses stemming from the contamination.
Aminosyn II is a food replacement IV drip that is used in patients who are unable to consume food the typical way. It can also be used to preserve protein and reduce the breakdown of sugars, fatty acids and proteins in stress conditions. Aminosyn II can also be used to prevent or reverse excreting more nitrogen than is taken in when feeding tubes should not be used.
The lot has an expiration date of April 1, 2022, and was manufactured by ICU Medical in November 2020. Hospitals and distributors should stop the use of the drug and return it to its place of purchase.
Anyone who believes they are experiencing side effects should contact their local doctor, as well as the FDA through its reporting feature on its website.
ICU Medical acquired the Hospira Infusion Systems from Pizer in Feb. 2017. The company manufactures IV compounding systems, as well as solutions, smart pumps and needle-free connectors.
In May, one lot of Hospira’s lidocaine hydrochloride injection was recalled after its label was switched with a lot of bupivacaine hydrochloride injection. That issue was identified after the FDA investigated a customer report, and marks the company’s second recall in just four months.