A nationwide IV recall

The FDA announced on September 9 that six lots of compounded IV wellness vials from Centric Compounding are being pulled. They went out nationwide, shipped directly to patients' homes and to prescribers.

What got pulled

Three lots of Glutathione 200 mg/mL, two lots of Myer's Cocktail, and one lot of Tri-Immune Boost, all 30 mL multidose vials.

The contaminated ingredient

All three were compounded with a glutathione active ingredient carrying elevated endotoxin levels. Endotoxins are pieces of the outer membrane of gram-negative bacteria, not living bacteria.

“They are components of the outer membranes of some bacteria like gram-negative bacteria”

Why a vein is different

Swallowing something gives your body a chance to filter it. An infusion skips that entirely, so endotoxins spread fast and set off a body-wide immune reaction.

“Intravenous exposure is very concerning because of bypasses [the body's] normal barriers to prevent infection.”

Nine people already sick

Centric Compounding has logged nine adverse event reports: fever, chills, chest pain, nausea, vomiting, headache, malaise. The FDA warns the worst cases can mean low blood pressure, anaphylactic shock, sepsis-like illness, or death.

What to do right now

Stop using the vials and throw them out. If you have fever, chills, aches, nausea, or redness at the injection site, go to an emergency room for bloodwork and blood cultures.

“If you are asymptomatic, I would still recommend getting bloodwork.”

Not an isolated case

Earlier this month B. Braun recalled three lots of saline injection after iron oxide, cellulose, and polystyrene particles turned up in it. The FDA is watching IV products closely.