The FDA announced on June 6, 2013 that it has identified bacterial and fungal growth in samples from two unopened vials of preservative-free (“PF”) methylprednisolone acetate (“MPA”) 80 mg/mL, 10mL vials manufactured by Tennessee-based Main Street Family Pharmacy, LLC (“Main Street”). The microbial growth was found in samples from two separate batches.
Because the FDA, along with the CDC, are still evaluating additional samples and lots of PF MPA and other sterile products produced by Main Street and are also working to identify the exact species of fungus and bacteria observed in the vials, the FDA has stated that the sterility of all sterile products produced by Main Street is questioned and advised against use of the products. The FDA’s June 6, 2013 announcement stated that it had received reports of adverse events, including skin and soft tissue abscesses, but was not aware of any cases of meningitis associated with Main Street’s preservative free methylprednisolone acetate for injection, as of June 6, 2013.
Main Street announced on May 28, 2013 a voluntary national recall of all of its sterile products compounded at its facility. The compounded products that are subject to the recall are those products with a use by date on or before November 20, 2013.
Main Street had announced in a press release on May 28, 2013 that the recall was due to seven reported cases of adverse events in the form of skin abscesses, one of which appears to be fungal in nature. Patients are at increased risk for serious infections in the event a sterile product is compromised. As of May 28, 2013, Main Street stated that it had only received reports of adverse events in three lots of preservative-free methylprednisolone acetate (MPA) and there had been no additional reports of injury or illness associated with the use of its sterile compounded products.
The FDA’s May 24, 2013 press release stated, “The U.S. Food and Drug Administration 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, 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. An investigation into the exact source of these adverse events is still ongoing, but these cases are associated with a potentially contaminated medication. As part of the ongoing investigation, the FDA will continue to work closely with the CDC and state authorities to thoroughly review the sterile practices at Main Street. Out of an abundance of caution, 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. The FDA asks health care providers and consumers to report adverse events or quality problems experienced with the use of any Main Street products to the FDA’s MedWatch Adverse Event Reporting program.”
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