Greenwich Rx Recalls Compounded Glutathione Due to Endotoxin Risks
Greenwich Rx is voluntarily recalling specific lots of its compounded glutathione injection to the consumer level because of potential elevated endotoxin levels. The affected products are supplied as 200 mg/mL in 10mL multidose vials intended for subcutaneous injection and were distributed nationwide between June and September.
Injectable products carrying elevated endotoxin levels present a risk of severe medical events, including fevers, hypotension, inflammatory reactions, anaphylactic shock, and death. The company has received two reports of patients requiring emergency department care after receiving intravenous administration of a product that was not formulated for IV use.
Customers in possession of the recalled lots are advised to stop using the product and follow the provided disposal instructions. Clinicians should be aware of these potential risks and advise patients to seek medical attention if they experience any related adverse health issues.
Key points
- Greenwich Rx is recalling multiple lots of compounded glutathione 200 mg/mL injection due to potential elevated endotoxin levels.
- Potential risks include fevers, hypotension, inflammatory reactions, anaphylactic shock, and death.
- Two patient reports have involved emergency department care following intravenous administration of a product not formulated for IV use.
- Patients and customers are advised to stop use, follow disposal instructions, and contact a healthcare provider if symptoms occur.
What it means for you
Clinicians and pharmacists should note the severe risks associated with endotoxin contamination in compounded injectables, including potential anaphylactic shock and death. Since this is an international FDA alert, practitioners in Pakistan should check with DRAP regarding local availability and safety advisories for similar compounded products.
Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin Levels
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.