FDA Finds Fungus In Tennessee Pharmacy Drugs

Posted: June 11, 2013 at 6:46 am

This post was added by Dr P. Richardson

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.

(MORE: Meningitis Outbreak Grows, Highlighting Dangers of Compounding Pharmacies)

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 Pharmacys 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 FDAs 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.

(MORE:Inside Americas Drug Shortage)

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FDA Finds Fungus In Tennessee Pharmacy Drugs

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