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[UPDATE 6/7/13: Bacterial and fungal growths have been identified in samples from two unopened vials of preservative-free Methylprednisolone Acetate 80mg/mL, 10mL vials. The FDA and CDC are working to identify the exact species of fungus and bacteria. Additional samples and lots are still under investigation.]
The FDA recommends that any sterile products compounded by Main Street Family Pharmacy be quarantined until further guidance is provided.
The FDA and the Tennessee Board of Pharmacy are investigating reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC of Newbern, TN. These adverse events are all from patients who received preservative-free methylprednisolone acetate 80mg/mL by injection.
RELATED: Endocrine Disorders Resource Center
Methylprednisolone acetate is a glucocorticoid indicated for various steroid-responsive disorders and local inflammation when oral therapy is not feasible. At least one of the reported infections appears to be a fungal infection.
The FDA is working closely with the CDC and state authorities to review the sterile practices at Main Street Family Pharmacy.
For more information visit the FDA website.
