Update on Main Street Family Pharmacy Products: Samples of injectable methylprednisolone acetate test positive for microbial contamination
[6/12/2013]
Today, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the Main Street Family Pharmacy (Main Street). An FDA Form 483 is issued when investigators observe any significant objectionable conditions. It does not constitute a final Agency determination of whether any condition is in violation of the Federal Food, Drug and Cosmetic Act (FFDCA) or any of our relevant regulations but the observations often serve as evidence of a violation of the FFDCA and its implementing regulations.
[6/6/2013]
As part of the ongoing FDA investigation of Main Street Family Pharmacy (Main Street) of Newbern, TN, 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. The microbial growth was seen in samples from two separate lots (batches).
| Medication | Lot Number | Preliminary Microbial Growth |
|---|---|---|
| PF MPA 80 mg/mL – 10 mL per vial | 011413dan | Bacterial and fungal |
| PF MPA 80 mg/mL – 10 mL per vial | 010913dan | Bacterial and fungal |
Additional samples and lots of PF MPA are still under evaluation, 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. We will share additional information as it becomes available.
FDA has received reports of adverse events, including skin and soft tissue abscesses. To date, we are not aware of any cases of meningitis associated with Main Street’s preservative free methylprednisolone acetate for injection. FDA will update this information as appropriate, as its investigation continues.
At this point in FDA's investigation, the sterility of all sterile products produced by Main Street is of significant concern and the products should not be used. On May 28, 2013, Main Street announced a voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy. The compounded products that are subject to the recall are those products with a use by date on or before November 20, 2013.