FDA: Tennessee pharmacy tainted

Bacteria, fungus found in vials

WASHINGTON — 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 Friday that it identified the growths in two unopened vials of a steroid injection distributed by the Main Street Family Pharmacy, a com- pounding pharmacy in Newbern, Tenn.

The agency said 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 said it is not aware of any cases of meningitis associated with Main Street Family Pharmacy’s products.

Last month the pharma- cy recalled its entire stock of sterile products manufactured after Dec. 6, 2012.

A spokesman for the Main Street Family Pharmacy said 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 con- cerns,” said spokesman Joe Grillo, in a statement.

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.