FDA warns compounders not to use glutathione from Letco Medical to compound sterile drugs

Agency is aware of adverse events related to compounded glutathione injection

[2/1/2019] FDA is warning compounders not to use glutathione-L-reduced powder distributed by Letco Medical, Decatur, Alabama, to compound sterile injectable drugs for patients. Based on reported adverse events, the agency has concerns with use of the Letco distributed glutathione to compound injectable drugs due to potential endotoxins.

Letco supplied this glutathione powder to about 100 compounders in 30 states. FDA urges compounders that use glutathione to make sterile injectable drugs to ensure the glutathione powder is appropriate for compounding sterile drugs, including checking with their supplier.

FDA is aware of seven patients who experienced various adverse events ranging from nausea and vomiting to difficulty breathing, which required one patient to be hospitalized immediately after receiving glutathione 200mg/mL intravenous injection. FDA believes high levels of endotoxin may have contributed to these adverse events. Following these reports, FDA has received varying third-party test results on the levels of endotoxin that may be present in Letco’s glutathione powder. FDA testing is underway.

Letco repackaged the glutathione into five sizes – 25gm, 50gm, 100gm, 500gm and 1kg – and distributed 13 lots with an expiration date of 6/17/2020:

1808030041
1808030042
1808030043
1808030044
1808030045
1808290090
1808290091
1808290092
1808290093
1810150048
1810150049
1810150050
1810150051

Health care professionals should check with their compounders regarding the source of the glutathione used to make sterile drugs for their patients. Patients who have concerns should talk to their health care professionals.

FDA is investigating this incident and will provide additional information as it becomes available.

Patients and health care professionals should report any adverse reactions related to the use of compounded glutathione to FDA’s MedWatch program:

Complete and submit the report online at www.fda.gov/medwatch/report.htm
Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178.