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FDA Discovers Microbial Contamination in Compound Pharmacy Products
FDA has identified bacterial and fungal growth in samples from two unopened vials from two separate lots of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials during investigation of Main Street Family Pharmacy of Newbern, TN. The agency is still evaluating additional samples and lots of PF MPA, as well as other sterile products produced by Main Street. FDA, in partnership with CDC, is working to identify the exact species of fungus and bacteria observed in the vials.
While FDA has received reports of adverse events, including skin and soft tissue abscesses, the agency stated on its website that it is “not aware of any cases of meningitis associated with Main Street’s preservative free methylprednisolone acetate for injection.” FDA, however, recommends that patients discontinue use of the products. Main Street issued a voluntary nationwide recall of all lots of all sterile products compounded by the company on May 28, 2013.