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.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.