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Main Street Family Pharmacy: Product linked to fungal contaminant

By Tim Sandle     May 26, 2013 in Health
The U.S. FDA is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy.
Another U.S. compounding pharmacy has hit the news in relation to potentially contaminated sterile medicines. Keen readers will note that the Digital Journal has run a series of news stories on the state of U.S. pharmacies and the recent round of inspections undertaken by the U.S. Food and Drug Administration (FDA).
All of this started back in October 2012, when the New England Compounding Center, due to a lack of quality control, release contaminated medicines that led to hundreds of people becoming infected with fungal meningitis through an injection intended to treat arthritis. Over fifty people died.
Potential fungal contamination also features with the Main Street Family Pharmacy issue, according to the FDA Medwatch service. The FDA's statement details reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn. The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection. To date, the FDA has received seven reports. Clinical information about these patients is pending; at least one of these infections appears to be fungal in nature.
The FDA report goes on further to state that an investigation into the exact source of these adverse events is ongoing. The report also notes that these cases are associated with a potentially contaminated medication. The FDA commits to work closely with the CDC and state authorities to thoroughly review the sterile practices at Main Street.
In addition, the FDA recommends that health care providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided. Federal authorities have identified five cases in Illinois and two more in North Carolina. The Illinois patients received injections at the Logan Primary Care clinic in the town of Herrin between Jan. 3 and Feb. 21, according to the Guardian.
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