Optimal Balance Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dentists who administer injectable glutathione (e.g., for adjunctive anti-oxidant or adjunctive periodontal protocols) must quarantine the affected Optimal Balance Pharmacy lot immediately to avoid potential endotoxin-related febrile or septic events in-office.
Key points
- Recall targets Compounded Glutathione 200 mg/mL, 30 mL multi-dose vials from Optimal Balance Pharmacy (Houston, TX) due to confirmed elevated endotoxin levels.
- Distribution is nationwide and recall is to the patient level, meaning any clinic inventory or dispensed doses must be returned or destroyed.
- Endotoxin exposure risk includes fever, chills, or septic shock; dental practices using compounded injectables for in-office procedures should verify lot numbers against their supplier records.
- No other glutathione products or other Optimal Balance compounded items are included in this action.
Who should care
Read the original on FDA Recalls
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