A Houston-based compounding pharmacy has pulled a batch of injectable glutathione from the market after in-house testing turned up dangerous bacterial toxins, with the product having reached patients across 14 states.
Glutathione injections are marketed to patients to combat cellular damage, strengthen the immune system, and help the liver clear out toxins, according to the pharmacy.
The company said it has already fielded reports of people getting sick after using the product. "To date, Optimal Balance Pharmacy has received reports of adverse events including fever, chills, severe headache, nausea, vomiting, pain, and symptoms consistent with an allergic reaction," the company said.
What Patients Should Do
Optimal Balance Pharmacy said it is reaching out directly to prescribers and patients by phone and mail to arrange the return and disposal of affected vials. Anyone holding the recalled product should immediately stop using it and set it aside, the company said. Patients and prescribers who already paid for the recalled vials are eligible for a full refund if they have not already been reimbursed. Anyone who used the product and experienced symptoms is urged to contact their prescribing physician.Questions about the recall can be directed to Optimal Balance Pharmacy at (218) 919-2964, available 9 a.m. to 5 p.m. CT, Monday through Friday. Adverse reactions or quality issues tied to the product can also be reported to the FDA's MedWatch program online, by mail or by fax. The FDA said it is aware of and monitoring the recall.
