Optimal Balance Pharmacy is voluntarily recalling one lot of compounded Glutathione Injection 200 mg/mL, supplied in 30 mL multi-dose vials, after pharmacy testing found elevated bacterial endotoxin levels.
The Houston-based pharmacy announced the patient-level, nationwide recall Aug. 19. The affected product is lot LG342009076, with an expiration date of Oct. 4, 2026. It was distributed directly to consumers in Arizona, Colorado, Florida, Illinois, Louisiana, Michigan, New York, Nevada, Oklahoma, Pennsylvania, Texas, Utah, Vermont and Washington.
Bacterial endotoxins can trigger severe reactions when present in injectable medicines. Optimal Balance said there is a reasonable probability that use of the affected product could cause fevers, hypotension, inflammatory reactions, anaphylactic shock or death.
The pharmacy said it has received adverse-event reports involving fever, chills, severe headache, nausea, vomiting, pain and symptoms consistent with an allergic reaction. The announcement did not specify the number of reports or whether patients required hospitalization.
Glutathione injection is used to help fight cell damage, support the immune system and clear toxins from the liver, according to the recall notice. The recalled product is a compounded drug, meaning it was prepared by the pharmacy rather than manufactured as an FDA-approved branded or generic medicine.
Optimal Balance said it is notifying prescribers and patients by telephone and mail. The company is arranging retrieval and proper disposition of the recalled vials.
The recall is being conducted with the knowledge of the FDA.
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