Additional NECC Products Test Positive for Bacterial Contamination, FDA Reports

FDA and Centers for Disease Control and Prevention (CDC) report that samples of two additional recalled New England Compounding Center (NECC) products, preservative-free injectable betamethasone and cardioplegia solution, have tested positive for bacteria. Previously, the fungus Exserohilum rostratum was identified in NECC-supplied, preservative-free methylprednisolone acetate that has been linked to the multistate fungal meningitis outbreak. Now FDA and CDC laboratories have identified bacteria present in three separate lots of NECC-supplied preservative-free injectable betamethasone and in a single lot of NECC cardioplegia solution.

FDA notes that the clinical significance of these results is not known and that the bacteria detected, Bacillus idriensis and Bacillus circulans, have been rarely reported as a cause of human disease. CDC continues to investigate reports of potential infections in patients receiving other NECC products. As of November 1, 2012, CDC has not received reports of laboratory-confirmed cases of infection due to Bacillus or closely related organisms linked to betamethasone or cardioplegia solution from NECC. Additional laboratory testing is ongoing, but FDA notes that results to date reinforce the agency’s concern about the lack of sterility in products produced at NECC’s compounding facility and serve to underscore that hospitals, clinics, and health care providers should not use any NECC-supplied products. All NECC products are subject to NECC’s recall announced on October 6, 2012. Additional details about test results available to date, and links to related FDA updates are available on the FDA Web site.

As of November 5, 2012, CDC reports that there are 419 cases of fungal meningitis, including 30 deaths, and 10 cases of peripheral joint infections. Of the 419 cases, a total of 119 have occurred in Michigan, 78 in Tennessee, 51 in Indiana, and 49 in Virginia, with the other 122 spread across Florida, Georgia, Idaho, Illinois, Maryland, Minnesota, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, and Texas.