According to a recent article in Time Magazine, the FDA announced that it discovered bacteria and fungus growing in vials of drugs manufactured at a Tennessee compounding pharmacy. The injectables produced by the Tennessee company were already recalled last month and have since been found to have caused injuries in patients living in North Carolina and Illinois.
The FDA issued a press release this week which said that it had identified the growths in several unopened vials of a steroid medication produced by Main Street Family Pharmacy which is located in Newbern, TN. The agency says it is working in coordination with the CDC to identify the exact strain of the bacteria and fungus found in the medications.
Officials launched an investigation into Main Street Family Pharmacy last month after seven individuals in North Carolina reported developing skin abscesses after being injected with a steroid used to treat inflammation and joint pain. The same steroid was involved in the deadly fungal meningitis outbreak that killed nearly 60 people last year. However, the FDA was quick to say that it not aware of any cases of meningitis associated with products produced by Main Street Family Pharmacy.
Unfortunately the recent issue with tainted injectables is not the first time Main Street Family Pharmacy has been in trouble with regulators. In March of this year the compounding pharmacy was fined $25,000 after inspectors found a variety of sterility problems at the facility.
Currently, the FDA says all products manufactured by the company after December 2012 are under a complete recall. The company says it is working hard to reach out to customers and doctors that might be affected to try and have the drugs pulled.
UPDATE: At the request of a member from Main Street Pharmacy, and in the spirit of being fair to both sides of this article, I'm including the following statement that was sent to me:
STATEMENT FROM MAIN STREET FAMILY PHARMACY
NEWBERN, TENNESSEE
UPDATED: Tuesday, June 17, 2013
“Main Street Family Pharmacy is aware of the FDA’s observations. We are working with the FDA and Tennessee Board of Pharmacy to implement new procedures and quality assurance measures to ensure that our products will continue to uphold the highest standards possible for the patients we serve.
“Since this matter surfaced, the pharmacy has done everything in its power to ensure that all potentially affected sterile compounded medicines are recalled and no longer used by consumers or healthcare providers. In addition to the voluntary recall, our efforts have also included comprehensive, aggressive outreach to everyone who could be affected. We continue to fully cooperate with state boards of health and pharmacies, the FDA and CDC to protect patients and resolve any lingering concerns.”
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