FDA MedWatch - Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials by Optimal Balance Pharmacy

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TOPIC: Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials by Optimal Balance Pharmacy: Recall - Due to Elevated Endotoxin Levels

AUDIENCE: Patient, Health Care Professional, Pharmacy

ISSUE: Optimal Balance Pharmacy is recalling one lot of Compounded Glutathione 200 mg/mL, 30 mL Multi-Dose Vials because pharmacy testing identified elevated bacterial endotoxin levels.

Risk Statement: 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.

To date, Optimal Balance Pharmacy has received reports of adverse events including fever, chills, severe headache, nausea, vomiting, pain, and symptoms consistent with an allergic reaction.

This compounded glutathione was distributed to consumers in Arizona, Colorado, Florida, Illinois, Louisiana, Michigan, New York, Nevada, Oklahoma, Pennsylvania, Texas, Utah, Vermont and Washington.

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

BACKGROUND: Glutathione Injection is used to help fight cell damage, support the immune system, and clear out toxins in the liver.

RECOMMENDATIONS: 

• Patients who have product which is being recalled should:

  • Stop using the product immediately and quarantine any product subject to this recall. Patients and prescribers will receive a full refund for recalled product if they have not already been reimbursed.

  • Contact Optimal Balance Pharmacy to arrange for retrieval and proper disposition of the recalled product.

  • Contact their prescribing physician if they have experienced any symptoms or problems that may be related to use of this product.

• Prescribers and patients with questions regarding this recall may contact Optimal Balance Pharmacy at (218) 919-2964.

Health care professionals 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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