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UPDATE: Multistate Investigation Associated with Steroid Injections
June 05, 2013
FOR IMMEDIATE RELEASE
June 5, 2013
Contact: Communications Office
TALLAHASSEE—The Florida Department of Health (DOH) today announced that Main Street Family Pharmacy of Newbern, TN has signed a Voluntary Agreement to Restrict Practice in Florida. This agreement legally mandates that the facility cease compounding sterile medications for Florida residents and cease the dispensing or shipping of sterile medications into Florida. Violation of these terms is cause for an emergency suspension of the facility’s license to practice pharmacy in the state of Florida.
DOH also announced that Southern Healthcare Rural Health Clinic of Bonifay did not receive the suspect methylprednisolone acetate (MPA) products compounded by the pharmacy in question. The clinic was previously identified as a facility in receipt of potentially contaminated MPA products associated with cases of adverse reaction to steroid injections. However, the facility’s updated invoice records, obtained in partnership with the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), reflect that the facility did not receive any compounded MPA products from the Main Street Pharmacy.
The facility’s records further reflect that a steroid product (methylprednisolone sodium succinate) produced by an outside manufacturer was distributed to the Florida facility. Main Street served only as the distributor. This product was outside the scope of the voluntary sterile products recall issued by Main Street.
This ongoing epidemiological investigation is being conducted by DOH in collaboration with the CDC, FDA, state partners and other state health departments. To date, no cases of meningitis or lifethreatening infections associated with the suspect product have been reported. At this time, all of Florida’s currently identified cases of adverse reaction are associated with skin abscesses following intra-muscular injections of MPA.
The list of Florida facilities in receipt of MPA products from Main Street pharmacy include: Family Health Care of Chipley, The Back Center of Melbourne and Dr. Parvesh Bansal, also of Melbourne. DOH has notified each of these facilities and is currently working with them to notify patients who may have been exposed.
Main Street has voluntarily initiated a recall of all sterile products, including MPA, in cooperation with state and federal authorities. Out of an abundance of caution, the FDA recommends all health care providers stop using any sterile products from Main Street and isolate them until further guidance is provided.
Any Florida health care licensee requiring assistance in reporting a potential adverse reaction following an injection of MPA is encouraged to contact their local county health department.
The Florida Department of Health works to protect, promote & improve the health of all people in Florida through integrated state, county, & community efforts.