Centric Compounding has recalled six lots of injectable Glutathione, Myer’s Cocktail and Tri-Immune Boost products nationwide after they were found to be compounded with a Glutathione active pharmaceutical ingredient containing elevated levels of endotoxins.
The recall covers 30 milliliter multidose vials distributed to patients through home delivery and to prescribers, according to a Sept. 13 FDA news release.
Centric Compounding received nine reports of fever, chills, chest pain, nausea or vomiting, headache and/or malaise. The company said injectable products with elevated endotoxin levels could cause significant medical events, including fevers, hypotension, inflammatory reactions, anaphylactic shock and death.
The company is arranging replacements for all recalled products. Consumers with affected Glutathione, Myer’s Cocktail and Tri-Immune Boost vials should stop using the products and discard them.