At-home IV products recalled over potentially fatal endotoxin risk
核心洞察
Centric Compounding LLC (搜索) recalled six lots of compounded injectable vials nationwide after elevated endotoxin (搜索) levels were found in the glutathione active pharmaceutical ingredient used to make them.
The recall, dated September 9, covers three lots of Glutathione 200 mg/mL, two lots of Myer's Cocktail (搜索) and one lot of Tri-Immune Boost (搜索), all 30 mL multidose vials.
Centric Compounding has received nine adverse event reports including fever, chills, chest pain, nausea, vomiting, headache and malaise, and the FDA warns of sepsis-like symptoms and death.
The FDA announced a nationwide recall of six lots of compounded intravenous wellness products from Centric Compounding LLC (搜索) after testing found elevated endotoxin (搜索) levels in the glutathione active pharmaceutical ingredient used to compound them. The September 9 action covers three lots of Glutathione 200 mg/mL 30 mL multidose vials, two lots of Myer's Cocktail (搜索) 30 mL multidose vials and one lot of Tri-Immune Boost (搜索) 30 mL multidose vials, distributed nationwide directly to patients through home delivery services and to healthcare prescribers.
Endotoxins are components of the outer membranes of gram-negative bacteria, and intravenous exposure bypasses the body's normal barriers to infection, allowing the toxins to circulate rapidly and activate immune cells. Centric Compounding reported nine adverse event reports linked to the products, with symptoms including fever, chills, chest pain, nausea, vomiting, headache and malaise. The FDA warned that exposure can lead to low blood pressure, inflammatory reactions, anaphylactic shock, sepsis-like symptoms and death. The recall follows a recent FDA warning advising compounders against using dietary supplement-grade glutathione in injectable products after reports of severe adverse reactions requiring hospitalization.
Centric Compounding said it is notifying customers and distributors by email to arrange replacements. The FDA urged patients holding affected vials to stop using them immediately and discard them, and to contact a healthcare provider if adverse symptoms occur; reactions can be reported through the agency's MedWatch program. The action comes amid heightened scrutiny of intravenous products after B. Braun Medical Inc. recalled three lots of 0.9% Sodium Chloride Injection USP (搜索), 100 mL, this month, following identification of particulate matter including iron oxide, cellulose and polystyrene particles in product distributed to hospitals and healthcare facilities between February and August 2026. B. Braun said it had received no reports of serious injuries, deaths or adverse events tied to the recalled saline.
Source: Newsweek