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TOPIC: Glutathione, Myer’s Cocktail, and Tri-Immune Boost by Centric Compounding: Recall - Due to Elevated Endotoxin Levels

AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Cardiology

ISSUE: Centric Compounding is recalling 6 lots of Glutathione 200 mg/mL, Myer’s Cocktail, and Tri-Immune Boost injectable vials because the products have been found to be compounded with a Glutathione API containing elevated endotoxin levels.

These products were distributed Nationwide to patients via home delivery and delivery to prescribers.

Risk Statement: There is a reasonable probability that injectable products with elevated endotoxin levels could cause significant medical events, including fevers, hypotension, inflammatory reactions, anaphylactic shock and death.

As of today, Centric Compounding has received 9 reports of fever, chills, chest pain, nausea/vomiting, headache, and/or malaise.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The products being recalled are used to support immunity, fatigue, and general wellness. 

RECOMMENDATIONS: 

• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

• Consumers with questions regarding this recall can contact Centric Compounding by phone at 833-777-6664 or info@centriccompounding.com.

Health care professionals, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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