By Elizabeth Landau
(CNN) — The U.S. Food and Drug Administration has identified bacterial and fungal growth in unopened vials of a steroid injection from a Tennessee pharmacy under investigation for links to reported infections.
Main Street Family Pharmacy of Newbern, Tennessee, issued a voluntary recall nationwide of all lots of sterile products that the pharmacy compounds on May 28. Products with a use by date on or before November 20, 2013, are subject to the recall.
The steroid in question is preservative-free methylprednisolone acetate. Samples from two separate batches were found to have microbial growth in them, the FDA said.
“At this point in FDA’s investigation, the sterility of all sterile products produced by Main Street is of significant concern and the products should not be used,” the FDA said.
As of Thursday, the Centers for Disease Control and Prevention reported 24 cases of infection from four states — Arkansas, Florida, Illinois and North Carolina. Most of these people developed skin and soft tissue infections after receiving the intramuscular injection of the steroid.
The FDA is not aware of any cases of meningitis linked to the steroid injections from the Main Street Family Pharmacy. A fungal meningitis outbreak last year was linked to methylprednisolone acetate from a compounding pharmacy in Massachusetts.
Other samples of this steroid and other products from Main Street are still being evaluated, the FDA said. The CDC is working with the FDA to identify which fungus and bacteria were detected in the vials.
The Tennessee Department of Health said May 24 that the pharmacy “is currently on probation as a result of a recent inspection.”
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.
“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.
Methylprednisolone 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 such as allergic reactions, sports-related injuries, immune system disorders, certain cancers and other types of inflammatory diseases.
CNN’s Michael Martinez and Matt Sloane contributed to this report.
The-CNN-Wire/Atlanta/+1-404-827-WIRE(9473)
™ & © 2013 Cable News Network, Inc., a Time Warner Company. All rights reserved.
