McGuff Compounding Pharmacy works diligently to ensure our Glutathione meets endotoxin limits that are safe for use

McGuff Compounding Pharmacy works diligently to ensure our Glutathione meets endotoxin limits that are safe for use

The FDA has issued an immediate warning regarding the Glutathione raw material purchased by over 100 compounding pharmacies in 30 states from Letco Medical, Decatur, Alabama. The FDA is aware of seven individuals who have suffered a range of symptoms (one patient was even hospitalized) after receiving intravenous Glutathione compounded with the use of raw materials from Letco Medical. It is believed that high levels of endotoxins are the cause of these adverse events.

McGuff Compounding Pharmacy DOES NOT purchase Glutathione raw materials from Letco Medical.


Let us explain how we protect you and your patients from endotoxins.

McGuff Compounding Pharmacy works diligently to ensure our sterile compounded injections meet endotoxin limits that are safe for use. The method McGuff Compounding Pharmacy uses to test is the well-known Gel-Clot method. This method is used to detect or quantify endotoxin levels based on the clotting of the LAL (Limulus Amebocyte Lysate) reagent to determine the presence of endotoxin. Endotoxin testing is performed to ensure that all injectable preparations are within safe endotoxin levels. McGuff Compounding Pharmacy performs endotoxin testing on every compounded sterile injection lot as a prerequisite for final release.

In addition to using the Gel-Clot method to test for endotoxins of our compounded injection preparations, McGuff Compounding Pharmacy uses preventative measures to screen for excessive endotoxin levels within our raw materials. Each incoming shipment of raw material to be used in injectable drugs is tested for the presence of endotoxin even before it is used for compounding. Also, our in-house water purification and distillation systems produce water for injection that meets the endotoxin levels set by the USP. Water for injection is used both as a raw material for injectable drugs as well as the final rinsing of labware used in sterile compounding.

McGuff Compounding Pharmacy continues to use the best quality of raw materials and quality systems in all of our compounded injectables. We do all the worrying so you don’t have to! If you have any questions, please do not hesitate to reach out to speak with a pharmacist at 1-877-444-1133.

For more information on this matter, please see the FDA warning:
http://app.info.fda.gov/e/es?s=2027422842&e=180568&elqTrackId=78D8A052C380BCBFF284D754BEBE9730&elq=2e5415b989f045539dcfe1f71e72888f&elqaid=6601&elqat=1

Endotoxin Limits for Parenteral Drug Products, White Paper
http://www.acciusa.com/pdfs/whitepapers/EndotoxinLimits_SeanJH-PR17-012.pdf