Greenwich Rx has issued a nationwide voluntary recall of specific lots of compounded glutathione injection because of potentially elevated endotoxin levels. The recalled product was distributed to patients from June 26 through Sept. 21.
The recall covers glutathione injection at 200 milligrams per milliliter in 10-milliliter multidose vials intended for subcutaneous injection. Ten lots are affected, with beyond-use dates ranging from Oct. 2 through Nov. 12.
Greenwich Rx, a 503A compounding pharmacy based in Tomball, Texas, said injectable products with elevated endotoxin levels could cause fever, low blood pressure, inflammatory reactions, anaphylactic shock or death.
The company reported receiving two reports involving patients who received emergency department care after intravenous administration of a glutathione product that was not formulated for intravenous use.
The recalled lots are 0060-062426-1, 0060-062726-1, 0060-070926-1, 0060-071426-1, 0060-071426-2, 0060-072026-1, 0060-072726-1, 0060-072926-1, 0060-073126-1 and 0060-080426-1.[
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