Microbial contamination has been identified in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC.
- Organisms identified include bacteria known as Bacillus, and fungal species including Aspergillus tubingensis, Aspergillus fumigatus, Cladosporium species, and Penicillium species.
Although rare, some of the identified Bacillus species can be human pathogens. Some of the fungal organisms identified, particularly Aspergillus fumigatus, are known to cause disease in humans. It is not known how product contamination with these organisms could affect patients clinically. To date, CDC and public health officials have no reports of laboratory-confirmed bacterial or fungal meningitis, spinal, or paraspinal infections caused by these products.
The available epidemiological and laboratory data do not, at this time, support evidence of an outbreak of infections linked to usage of non-methylprednisolone NECC products.
CDC continues to recommend that clinicians remain alert for the possibility that infections may have resulted from injection of NECC products, and that routine laboratory and microbiologic tests, including bacterial and fungal cultures, should be obtained as deemed necessary by treating clinicians. Clinicians should continue to report infections potentially related to NECC products to FDA’s MedWatch and to state health departments.
Additional information about management of patients with central nervous system and localized infections associated with injection of contaminated steroid products is available at http://www.cdc.gov/hai/outbreaks/clinicians/index.html.
As a reminder, all patients exposed to the three implicated lots of methylprednisolone acetate in North Carolina have been contacted individually. Please contact the NC Division of Public Health epidemiologist on call at 919-733-3419 with questions or to report any patients experiencing complications associated with this outbreak.