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Contamination identified in additional medical products from New England Compounding Center
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11/01/2012
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Series: HAN ; 333
[PDF-1.53 MB]
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Description:November 1, 2012, 18:00 ET (6:00 PM ET)
CDC HAN-00333-2012-11 -01-ADV-N
Summary: 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. NECC is the firm that distributed and recalled injectable steroid medications implicated in the current outbreak of fungal meningitis and other infections. CDC and FDA are reporting today that product testing has identified bacterial contamination with several Bacillus species and closely related bacterial organisms in unopened vials of betamethasone and cardioplegia solution that were distributed and later recalled by NECC on October 6, 2012. These bacteria are commonly found in the environment and have been rarely reported as a cause of human disease; it is not known how product contamination with these species might affect patients. Although clinical infection is possible, CDC has not received reports of laboratory-confirmed cases of infection due to Bacillus or closely related organisms linked to these 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. Additional microbial organisms may be identified in recalled NECC products as additional laboratory testing is completed.
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