FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections

Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions

Associated with Steroid Injections

[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:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm
• Download      and complete the form, then submit it via fax at 1-800-FDA-0178

Read the Medwatch safety alert, including a link to the FDA Update, at:

http://www.fda.gov//SafetyAlertsforHumanMedicalProducts/ucm353953.htm

Source: http://www.fda.gov/