FDA finds fungus in drugs from Tennessee pharmacy

WASHINGTON (AP) - 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 compounding 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 pharmacy 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 concerns," 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.

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According to a consent order, the 2011 inspection found out-of-date medications on the pharmacy's shelves that were being used in drug manufacturing.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 When inspectors returned in November 2012 they found 109 out-of-date or deteriorated medications on the shelves, as well as other problems.


(Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.)

Top Stories

  • Stolen Celebration
    Thieves have stolen all the decorations for Seattle's popular Halloween Alley

  • Commitment
    A Boeing CEO says Everett's new 777X wing facility is a sign of commitment

  • All You Can Eat
    6 belt-loosening food challenges in Seattle you may not be man enough to complete
ATTENTION COMMENTERS: We've changed our comments, but want to keep you in the conversation.
Please login below with your Facebook, Twitter, Google+ or Disqus account. Existing MyNorthwest account holders will need to create a new Disqus account or use one of the social logins provided below. Thank you.
comments powered by Disqus
Sign up for breaking news e-mail alerts from MyNorthwest.com
In the community
Do you know an exceptional citizen who has impacted and inspired others?
KIRO Radio and WSECU would like to recognize six oustanding citizens this year. Nominate them to be recognized and to receive a $2,000 charitable grant.