Optimal Balance Pharmacy has announced a voluntary nationwide recall of specific lots of its compounded Glutathione 200 mg/mL multi-dose vials. The recall stems from elevated endotoxin levels discovered during routine testing, which pose potential risks to patient safety.
According to the FDA MedWatch Safety Alerts, the presence of elevated endotoxins in injectable products can cause significant health issues. Patients exposed to these contaminants might experience severe symptoms such as fever, hypotension, inflammatory reactions, anaphylactic shock, and even death.
Reports have confirmed that adverse effects, consistent with allergic reactions, have already been observed among users. The affected vials were distributed across several states, including Arizona, Colorado, Florida, and New York, among others.
Recommendations for Patients and Prescribers:
- Immediate Action: Stop using the recalled product and quarantine it.
- Contact: Reach out to the pharmacy for the retrieval and proper disposal of the vials. Patients will be reimbursed for the recalled products.
- Medical Attention: Consult with a healthcare provider if any symptoms arise from using the product.
Ensuring safety, Optimal Balance Pharmacy is actively reaching out to prescribers and patients via phone and mail notifications.