June 7, 2013
The US Food and Drug Administration (FDA) has identified bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials form Main Street Family Pharmacy. The microbial growth was seen in samples from two separate lots (batches). Additional samples and lots of PF MPA are still under evaluation, as well as other sterile products produced by Main Street.
The FDA, in partnership with the Centers for Disease Control and Prevention (CDC), is working to identify the exact species of fungus and bacteria observed in the vials. The FDA has received reports of adverse events, including skin and soft tissue abscesses. To date, the FDA is not aware of any cases of meningitis associated with Main Street’s preservative free methylprednisolone acetate for injection.
The FDA asks health care providers and consumers to report adverse events or quality problems experienced with this or any Main Street products to the FDA’s MedWatch Adverse Event Reporting program:
Read the Medwatch safety alert and download a Patient Notification Toolkit from the CDC.