Centric Compounding is recalling six lots of three immune booster products sold nationwide due to high levels of endotoxins.
One of the products subject to recall is Glutathione 200mg/ml 30mL vial, with lot number 062326:B and expiration date of Aug. 7; lot number 070826:A with Aug. 22 date; and 072726:D with expiry on Sept. 25, Texas-based Centric Compounding said in a company announcement published by the Food and Drug Administration on Sept. 13.
Myer’s Cocktail 30mL vials with lot numbers 070226:D (expiration date Aug. 16) and 072126:A (expiration date Sept. 4) are being recalled. The third product being withdrawn from the market is the Tri-Immune Boost 30mL vial, lot number 071626:B, with an Aug. 30 expiry date.
In addition to supporting immunity, the products help tackle fatigue and support overall wellness.
The items were found to be compounded with a glutathione active pharmaceutical ingredient containing high endotoxin levels. Endotoxins are toxic components from the outer membranes of certain bacteria. All recalled products were sold across the United States to prescribers and patients.
“There is reasonable probability that injectable products with elevated endotoxin levels could cause significant medical events including fevers, hypotension, inflammatory reactions, anaphylactic shock and death,” Centric Compounding warned.
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Endotoxins are also linked to adverse effects such as sepsis syndrome, immunotoxicity, dental diseases, neurotoxicity, cancer, and respiratory illnesses, according to a study published in the Toxicology Letters journal. Endotoxins can enter drugs through ingredients used to make the drugs.
Bacteria release endotoxins into the environment during cell growth, division, and death. Endotoxin contamination can be found across diverse settings, from drug products and medical devices to air and water.
Centric Compounding said in the announcement that it has so far received nine reports of customers suffering from chills, chest pain, headache, fever, malaise, and nausea/vomiting. It advised people who experience any problems after using the products to contact their healthcare provider.
The company asked customers to stop using the recalled items and discard the affected vials, notified customers and distributors about the issue, and is currently arranging replacements, according to the announcement. Consumers with queries can contact the company at 833-777-6664.
The Epoch Times reached out to Centric Compounding for comment but did not receive a response by publication time.
When endotoxins enter the human body, they trigger an immune response, which can lead to a series of inflammatory conditions, according to the European Biomedical Institute.
Exposure to even small amounts of endotoxins can trigger serious immune reactions. Medical devices, such as those used in surgery, must meet stringent requirements to prevent endotoxin-related adverse effects.
The commonly used method for detecting endotoxins is the Limulus Amebocyte Lysate test, which uses horseshoe crab blood.
Meanwhile, the FDA issued an alert on Aug. 27, highlighting high endotoxin levels in certain compounded glutathione injectable drugs.
The agency said it is aware of reports of at least 30 individuals who suffered adverse events after using glutathione intravenously. The glutathione was prepared by multiple compounding pharmacies.
According to the FDA, the glutathione was labeled “dietary supplement grade,” which is inappropriate for use in injectable drugs.
“Compounders are responsible for ensuring all components used in injectable drugs are appropriate for their intended use and should not use dietary supplement grade ingredients when making injectable drugs,” the FDA said.
“Ingredients labeled for dietary supplement use may contain impurities and contaminants, including endotoxins, that may be harmful when administered as an injectable drug.”
At the time, the FDA said it continued to receive adverse event reports consistent with endotoxin exposure.
