Additional Contamination Identified in Medical Products from New England Compounding Center


As part of the ongoing investigation of the multistate outbreak of fungal meningitis and other infections, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) continue to test medical products from the New England Compounding Center (NECC) in Framingham, Mass. The CDC and FDA are reporting additional microbial contamination identified in NECC products, which updates the Nov. 1, 2012 Health Alert Network advisory.

This update includes the following key points:

- CDC and FDA have identified additional microbial contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC.

- These 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, although CDC has received reports of illness in patients who have received the medications listed in the table below, including some patients who had evidence of meningeal inflammation, 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's recommendations to healthcare providers for diagnosing and treating symptomatic patients who have received NECC products have not changed as a result of these findings.

- 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.
On Sept. 26, 2012, NECC voluntarily recalled three lots of preservative-free methylprednisolone acetate (PF) 80mg/ml1 associated with the multistate outbreak of fungal meningitis and other infections. As previously confirmed by CDC and FDA, the fungus Exserohilum rostratum was identified from two different lots of NECC-supplied, preservative-free methylprednisolone acetate; testing on the third implicated lot of preservative-free methylprednisolone acetate has yet to identify fungal growth.  Two types of fungus not known to be human pathogens were also identified from product from the two tested lots, namely Rhodotorula laryngis and Rhizopus stolonifer. Among these fungal organisms, only Exserohilum rostratum has been associated with human infections in this outbreak.
On Oct. 6, NECC expanded its recall to include all products in circulation that were distributed from its facility in Framingham, Mass.  As part of the ongoing investigation, FDA and CDC have been testing various NECC products for evidence of contamination. Laboratory testing at CDC and FDA has found bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC.

For a table of contaminated products, CLICK HERE.

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