The Food and Drug Administration has found bacteria and fungus in vials of pain shots made by a Tennessee pharmacy whose products have been linked to infections.
FDA said it found the contaminants in two sealed vials of steroids made by Main Street Family Pharmacy, which has recalled all its products nationwide after 24 people in Arkansas, Florida, Illinois and North Carolina developed abscesses at the sites where they got the injections.
“FDA, in partnership with the Centers for Disease Control and Prevention, is working to identify the exact species of fungus and bacteria observed in the vials. FDA has received reports of adverse events, including skin and soft tissue abscesses,” FDA said in a statement.
“To date, FDA is not aware of any cases of meningitis associated with Main Street’s preservative free methylprednisolone acetate for injection.”
The injections contain the same drug at the center of last year's deadly outbreak of fungal meningitis. CDC says 58 people have died and 745 others developed infections after receiving contaminated injections from the New England Compounding Center in Massachusetts. More than 300 cases involved abscesses or similar infections.
Tennessee state officials say the facility distributed the products to 13 states: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas. CDC says it is checking to see if more people may be at risk.
Since the outbreak linked to the Massachusetts pharmacy, FDA and state officials have stepped up inspections of compounding pharmacies, and found many operating with unsterile conditions.
“The FDA asks health care providers and consumers to report adverse events or quality problems experienced with this or any Main Street products to the FDA’s MedWatch Adverse Event Reporting program,” the agency said.
- Twenty now sick in outbreak linked to contaminated shots
- FDA warns of injections linked to Tenn. pharmacy
- More bacteria, fungi found in drugs made by Mass. pharmacy