The Food and Drug Administration (FDA) is working closely with the Centers for Disease Control and Prevention (CDC) and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC of Newbern, Tenn.
Out of an abundance of caution, the FDA recommends that healthcare providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided.
The reports of adverse events are all from patients who received preservative-free methylprednisolone acetate (80 mg/mL) by injection. To date, the FDA has received seven reports. Clinical information about these patients is pending; at least one of these adverse events appears to involve fungus.
An investigation into the exact source of these adverse events is still ongoing, but these cases are associated with a potentially contaminated medication. As part of the ongoing investigation, the FDA will continue to work closely with the CDC and state authorities to thoroughly review the sterile practices at Main Street.
The FDA asks healthcare providers and consumers to report adverse events or quality problems experienced with the use of any Main Street products to the FDAs MedWatch Adverse Event Reporting program at: www.fda.gov/medwatch/report.htm