NASHVILLE, Tenn. -- Six months after state officials found multiple violations at a West Tennessee compounding pharmacy but did not shut it down, the pharmacy is the apparent source of infections in two states.
Main Street Family Pharmacy LLC in Newbern recalled all its sterile products, the U.S. Food and Drug Administration said Friday, after methylprednisolone acetate it made was linked to seven cases of injection site inflammation in Illinois and North Carolina. One of the cases appears to involve a fungus, the FDA said.
The drug is the same steroid blamed for an ongoing fungal meningitis outbreak that has killed 55 patients nationwide, including 15 in Tennessee.
Louisiana is among the states that received recalled shipments from Main Street Family Pharmacy LLC. The others are Alabama, Arkansas, California, Florida, Kentucky, Illinois, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.
State and federal health officials cautioned that they do not know the scope of the problem. The number of people exposed to the suspect medicine is not known.
State inspectors found issues at the pharmacy the month before the suspect medicine was shipped but allowed it to continue to operate.
“Fortunately, we are aware inueof no serious events like meningitis, stroke or death in association with this cluster, but still our hearts go out to those affected by this event,” said Tennessee Health Commissioner Dr. John Dreyzehner. “It is very important to note that based on everything we know right now, this situation does not approach the severity of the fungal infections outbreak we encountered in the fall of 2012.”
However, he noted that the information could change.
“This is very early in this rapidly evolving investigation,” Dreyzehner said. “We expect that we will receive additional facts that will be very important to this investigation.”
--Clients haven't been identified
The primary focus at this point is sequestering all the sterile products shipped by Main Street Family Pharmacy and to contact patients who might have received injections with the steroid — a common treatment for chronic pain.
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