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.

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.