May 28, 2013
The US Food and Drug Administration (FDA) 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, Tennessee.
Out of an abundance of caution, the FDA recommends that health care 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.
Healthcare 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 the pre-addressed form, or submit by fax to 1.800.FDA.0178
Read the MedWatch safety alert.