- Main Street Family Pharmacy in Tennessee voluntarily recalls steroid product in 11 states
- Five people in Illinois develop abscesses; two complications develop in North Carolina
- The pharmacy is currently on probation as a result of a recent inspection
- No cases of meningitis or other life-threatening infections have been reported
A Tennessee compounding pharmacy on probation has voluntarily recalled an anti-inflammatory steroid injection in at least 11 states after seven patients developed abscesses in North Carolina and Illinois, officials said Friday.
State and federal health organizations are investigating Main Street Family Pharmacy, LLC, in Newbern, Tennessee, and its preservative-free methylprednisolone acetate, or MPA, a steroid product used for a range of conditions.
The pharmacy "is currently on probation as a result of a recent inspection," the Tennessee Department of Health said in a statement. The agency didn't provide further details.
The Tennessee Board of Pharmacy licensed the compounding pharmacy in 1985, the state health agency said. It was licensed as a manufacturer/wholesaler/distributor in 2010, the state agency said.
Officials with the compounding pharmacy couldn't be immediately reached for comment Friday.
Cooperating with authorities, the pharmacy has voluntarily recalled all of its sterile products, including MPA, authorities said.
No cases of meningitis or other life-threatening infections have been reported, authorities said.
"Health officials believe, in reviewing preliminary information about when the material could have been appropriately used, there is not an ongoing risk to those now needing treatments," the Tennessee health agency said.
Melthyprednisone acetate is an injectable form of a popular steroid medication and is used to treat inflammation throughout the body. It's most commonly used to treat arthritic joint pain, but can also be used for other conditions like allergic reactions, sports-related injuries, immune system disorders, certain cancers and various other types of inflammatory diseases.
In the wake of the recent complications, the Food and Drug Administration and Tennessee health officials began inspecting the facility on Wednesday.
"The pharmacy staff and management have been cooperative," the state health agency said. "The pharmacy has agreed to stop sterile compounding pending resolution of the current investigation."
Five people in Illinois developed abscesses after receiving injections of MPA, state health authorities said. All five Illinois patients received the shots at Logan Primary Care clinic in Herrin between January 3 and February 21, officials said.
Two people in North Carolina developed complications after receiving the injections at a clinic in Greenville, state health officials said. The pharmacy shipped MPA to a total of three North Carolina clinics: Carolina Arthritis Center in Pitt County, Bailey Family Practice Center in Nash County, and Shallote Medical Center in Brunswick County. State and local health officials are now working with those three facilities.
Illinois health authorities said that one of the cases in North Carolina "indicates a fungal infection as the cause of an abscess that developed after injection with MPA from the compounding pharmacy."
North Carolina authorities said skin abscesses have been the complications identified so far. The Tennessee pharmacy "has agreed to voluntary surrender its North Carolina pharmacy license," according to a statement by North Carolina Board of Pharmacy and the North Carolina Department of Health and Human Services.
Besides Illinois and North Carolina, the Tennessee pharmacy has distributed the steroid injection to nine more states: Alabama, Arkansas, California, Florida, Kentucky, Louisiana, Mississippi, New Mexico, and South Carolina.