Pharmaceutical

FDA identifies fungus, bacteria in steroid shots made by Tenn. pharmacy

syringe FDA identifies fungus, bacteria in steroid shots made by Tenn. pharmacyFederal investigators have identified bacterial and fungal growth in two unopened steroid injections used by medical facilities to treat back or joint pain, manufactured by Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.

The vials of preservative-free methylprednisolone acetate (MPA) are the same type of compound that has sickened at least 745 people with fungal infections including fungal meningitis, and killed 58. Those injections were compounded by New England Compounding Center, a Massachusetts-based pharmacy.

To date, seven infections, none of which appear to be meningitis, but no deaths have been reported in patients who received the Main Street Pharmacy shots. The vials were distributed to medical facilities in 13 states including Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.

On May 28, following the adverse event reports, Main Street Family Pharmacy issued a nationwide recall on all lots of sterile products compounded by the pharmacy. The Food and Drug Administration (FDA) launched an investigation and found bacterial and fungal contaminates in two vials from two separate batches of steroid shots.

Additional samples and lots are currently under investigation. The FDA is also working with the Centers for Disease Control and Prevention (CDC) to identify the exact species of fungus and bacteria observed in the vials.

Source: FDA