What happened
Centric Compounding voluntarily recalled six lots of compounded Glutathione 200 mg/mL, Myer’s Cocktail, and Tri-Immune Boost injectable products to the consumer level after finding that they were compounded with Glutathione API containing elevated endotoxin levels. The affected products are 30 mL multidose vials distributed nationwide to patients and prescribers. The company reported nine accounts of symptoms including fever, chills, chest pain, nausea/vomiting, headache, and/or malaise. It warned that injectable products with elevated endotoxin could cause serious events, including hypotension, inflammatory reactions, anaphylactic shock, and death. Customers are being notified, replacements arranged, and consumers instructed to stop using and discard affected vials.
Why it matters
From a GMP and pharmaceutical manufacturing perspective, the source’s attribution of elevated endotoxin to the Glutathione API makes microbiological control of incoming materials, materials management, and supplier qualification particularly relevant. Because the products are injectable multidose vials and the recall followed reported patient symptoms, the announcement also highlights the potential patient impact of elevated endotoxin in compounded injectables and the importance of effective recall execution. The source does not identify a specific manufacturing-system root cause beyond the API finding.
Key topics: Elevated endotoxin in Glutathione API, Nationwide recall of compounded injectable multidose vials, Reported adverse reactions associated with recalled lots