The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and
Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events
associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) 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 FDA’s MedWatch1
Adverse Event Reporting program:
Complete and submit the report online Click Here
Download and complete the form, then submit it via fax at 1-800-FDA-0178