FDA Finds Fungus in Specialty Steroids
Federal health officials say they have found bacteria and fungus in drug vials from a Tennessee specialty pharmacy that recalled all of its injectable medicines last month.
The Food and Drug Administration said in an online posting that it identified the growths in two unopened vials of a steroid injection distributed by the Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn. The agency says it is working with the Centers for Disease Control and Prevention to identify the exact species of fungus and bacteria.
State and federal officials began investigating the pharmacy last month after seven patients in North Carolina and Illinois reported skin abscesses after being injected with methylprednisolone acetate, a steroid used to treat inflammation, joint pain and respiratory issues.
The same steroid was involved in a deadly fungal meningitis outbreak last year that has killed 58 people and sickened more than 740 others.
The FDA says it is not aware of any cases of meningitis associated with Main Street Family Pharmacy's products.
Last month the pharmacy recalled its entire stock of sterile products manufactured after Dec. 6, 2012.
A spokesman for the Main Street Family Pharmacy says its owners are aware of the FDA's findings.
"In addition to the recall, our efforts have also included comprehensive, aggressive outreach to everyone who could be affected. We continue to fully cooperate with state boards of health and pharmacies, the FDA and CDC to protect patients and resolve any lingering concerns," says spokesman Joe Grillo.
The company's steroid was shipped to medical facilities in 13 states: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.
The Main Street Family Pharmacy's license was placed on three-year probation in March and its owners were fined $25,600 after a pair of inspections found various problems at the facility.
According to a consent order, the 2011 inspection found out-of-date medications on the pharmacy's shelves that were being used in drug manufacturing. It also found a technician who had been working without proper registration for more than four years. When inspectors returned in November 2012 they found 109 out-of-date or deteriorated medications on the shelves, as well as other problems.