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Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections

June 13, 2013

Audience: Patients, Health Professionals

[UPDATE 06/13/2013] FDA identified the specific bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials. See the 06/13/2013 link below for lot numbers and microbial identification information.

6/13/2013 Update on Main Street Family Pharmacy Products

[UPDATE 06/07/2013] 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. FDA, in partnership with CDC, is working to identify the exact species of fungus and bacteria observed in the vials. FDA has received reports of adverse events, including skin and soft tissue abscesses. To date, 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:

[UPDATE 05/28/2013] Main Street Family Pharmacy, LLC has 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 with a use by date on or before November 20, 2013. The recall is being initiated due to seven (7) reported cases of adverse events in the form of skin abscesses, one of which appears to be fungal in nature. An investigation into the exact source of the adverse events is still ongoing.

These products were supplied to the offices of licensed medical professionals and patients. Sterile products included in this withdrawal were distributed nationwide.

Refer to the Firm Press Release for the list of products being recalled.

[Posted 05/24/2013]

ISSUE: The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn. The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection. To date, the FDA has received seven reports. Clinical information about these patients is pending; at least one of these infections appears to be fungal in nature.

BACKGROUND: An investigation into the exact source of these adverse events is still ongoing, but these cases are associated with a potentially contaminated medication. As part of the ongoing investigation, the FDA will continue to work closely with the CDC and state authorities to thoroughly review the sterile practices at Main Street.

RECOMMENDATION: Out of an abundance of caution, the FDA recommends that health care providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided.

The FDA asks 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:

[06/06/2013 - Update on Main Street Family Pharmacy Products - FDA
[05/30/2013 - Multistate Outbreak of Infections Following Steroid Injections - CDC]
[05/28/2013 - Firm Press Release - Main Street Family Pharmacy]
[05/24/2013 - Press Release - FDA]

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