FDA: Fungal growth in unopened vials of steroid

June 10, 2013 at 5:49 PM
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NEWBERN, Tenn., June 10 (UPI) -- U.S. officials say they have found bacterial and fungal growth in unopened vials of steroid injection from a Tennessee pharmacy already under investigation.

The Main Street Family Pharmacy of Newbern was already under investigation for reported infections. The pharmacy issued a nationwide voluntary recall May 28 on all lots of sterile products the pharmacy compounds, the U.S. Food and Drug Administration said.

The FDA said products with a use-by date on or before Nov. 20 are subject to the recall.

CNN said the steroid is preservative-free methylprednisolone acetate. The FDA samples from two batches had microbial growth in them,

The Centers for Disease Control and Prevention said by Thursday there were 24 cases of infection reported from four states, Arkansas, Florida, Illinois and North Carolina.

CNN said most people affected developed skin and soft tissue infections after receiving the steroid injunction.

The FDA said it is not aware of any meningitis linked to the steroid injections from the Main Street Family Pharmacy. A fungal meningitis outbreak last year was linked to methylprednisolone acetate from a compounding pharmacy in Massachusetts.

Methylprednisolone acetate is an injectable form of steroid used to treat inflammation throughout the body, CNN said.

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