FDA finds fungus in drugs from Tennessee pharmacy

WASHINGTON (AP) — Federal health officials say they have found bacteriaand 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 compounding pharmacy in Newbern, Tenn. Theagency 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 methylprednisoloneacetate, a steroid used to treat inflammation, joint pain and respiratoryissues. The same steroid was involved in a deadly fungal meningitis outbreaklast 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 pharmacy recalled its entire stock of sterile products manufactured afterDec. 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 couldbe affected. We continue to fully cooperate with state boards of health and pharmacies, the FDAand CDC to protect patients and resolve any lingering concerns," said spokesman JoeGrillo, in a statement. The company's steroid was shippedto medical facilities in 13 states: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennesseeand Texas. The Main Street Family Pharmacy's license was placed on three-year probation in March and its owners werefined $25,600 after a pair of inspectionsfound 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 According to a consent order, the 2011 inspection found out-of-date medications on the pharmacy's shelves that were being used in drug manufacturing.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 When inspectors returned in November 2012 they found 109 out-of-date or deteriorated medications on the shelves, as well as other problems.