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.
FDA Form 483 (PDF - 873KB)
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).
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.
Clinics or customers with product on hand should contact Main Street Family Pharmacy, LLC by phone at 731-627-2221 or 888-658-6200 from the hours of 8:30 AM - 6:00 PM Central Standard Time Monday-Friday or by email email@example.com to obtain instructions on how to return products.
FDA will continue to work closely with CDC and state authorities during the ongoing investigation. Suspected infections meeting CDC's case definition and the states reporting them will continue to be updated on CDC’s website at http://www.cdc.gov/hai/outbreaks/TN-pharmacy/index.html.
FDA reminds 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:
Health care providers and patients may call the FDA's Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the recall and speak directly with a pharmacist.
For more information:
CDC: Multistate Outbreak of Suspected Infections Following Steroid Injections
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