As a result of an investigation initiated in May 2013, FDA has identified bacterial and fungal growth in products compounded by Main Street Family Pharmacy of Newbern, TN. The microbial growth was found in samples from two separate lots (lot number 011413dan and lot number 010913dan) of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/ml, 10 ml vials. FDA has received reports of adverse events associated with the products, including skin and soft tissue abscesses, but the agency is not aware of any cases of meningitis associated with the products. Main Street Family Pharmacy initiated a recall of all sterile products in May 2013. 

FDA and the Centers for Disease Control and Prevention are evaluating additional samples and lots of PF MPA produced by Main Street Family Pharmacy. The agencies are working to identify the exact species of fungus and bacteria observed in the vials. FDA indicates that health care providers and patients may call the FDA's Drug Information Line at 855/543-3784 (press *) for the most recent information regarding the recall and to speak directly with a pharmacist. Additional information is available in an FDA news release.