Federal drug inspectors indicate that bacteria and fungus have been found in vials of epidural steroid injections made by Main Street Pharmacy, a Tennessee compounding center that issued a recall last month for all of its products after infections were reported among patients.
The FDA issued a report on June 6, which states that two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) made by Main Street Family Pharmacy contained bacterial and fungal growth. The vials were from two separate lots.
Amid reports of infections from the pain injections, the pharmacy was forced to recall at all of its supposedly sterile drugs on May 24. At that time, at least seven patients who received Main Street Pharmacy epidural steroid injections reported adverse events in the form of abscesses. That number has since grown to 24 patients who developed skin and soft tissue infections in at least four states, including Arkansas, Florida, Illinois, and North Carolina.
The circumstances are very similar to those that led to a nationwide fungal meningitis outbreak late last year from recalled epidural steroid injections mixed by the New England Compounding Center.
Those vials were also found to be contaminated with fungus, which has been blamed for sickening more than 700 people nationwide and causing the deaths of nearly 60 people. Individuals continue to fight the effects of infections, and NECC faces a number of fungal meningitis lawsuits filed by individuals throughout the U.S.
To date, no reports of meningitis have been linked to Main Street Family Pharmacy drugs. Although the FDA has advised against using any of the pharmacy’s products, the drugs identified as contaminated by investigators were lots 011413dan and 010913dan of PF MPA 80 mg/mL, 10 mL vials.
All of the compounding pharmacy’s products are under investigation by the FDA, the U.S. Centers for Disease Control and Prevention(CDC) and state health agencies. The bacteria and fungus found in the vials has not yet been identified.
The CDC has created a webpage where future updates on Main Street Family Pharmacy infection outbreak will be posted.