Fungus the Culprit in Another Injection Recall, Illness OutbreakJun 10, 2013
The U.S. Food and Drug Administration (FDA) recently announced that it is collaborating with the U.S. Centers for Disease Control and Prevention (CDC) and the Tennessee Board of Pharmacies to investigate adverse event reports associated with steroid injections compounded by Main Street Family Pharmacy LLC of Newbern, Tennessee.
The agency said it has identified bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials from Main Street Family Pharmacy; microbial growth was seen in samples from two separate lot batches. Other samples and lots of PF MPA are under evaluation, as are other sterile products produced by Main Street.
MPA is the drug that was the focus of last year’s deadly fungal meningitis outbreak. In that outbreak, 55 people died and over 740 more were sickened after having received tainted injections from a Massachusetts compounding pharmacy.
The FDA has received seven reports of adverse events, including skin and soft tissue abscesses. Meanwhile, Main Street Family Pharmacy, LLC announced a voluntary nationwide recall of all lots of all sterile products it has compounded.
The compounded products subject to the recall are those with a “use by” date of on or before November 20, 2013 and were supplied to the offices of licensed medical professionals and patients; sterile products included in the recall were distributed nationwide to Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee, and Texas. A complete breakdown of the recalled products can be accessed at: http://www.fda.gov/Safety/Recalls/ucm354182.htm.
The recall followed seven adverse event reports that include skin abscesses, one which appears to be fungal. An investigation into the exact source of the adverse events continues.
Main Street Family Pharmacy is a compounding pharmacy. Compounding pharmacies manufacture custom drug formulations based on doctors' specifications. Since last year’s outbreak, the FDA has increased compounding pharmacy inspections nationwide, with inspections having led to a number of recalls of potentially contaminated medications, according to The Associated Press (AP).
Main Street Family Pharmacy’s licenses were placed on a three-year probation in late March and the firm was assessed a $25,600 fine after two inspections revealed a number of problems. According to the consent order, a 2011 inspection revealed out-of-date drugs being used in the manufacture of compounded drugs and that a technician had been working there without appropriate registration for more than four years. A 2012 inspection revealed 109 out-of-date or deteriorated drugs on the shelves, in addition to other issues, according to the AP.