November 2, 2012
Product testing has identified bacterial contamination in unopened vials of betamethasone and cardioplegia solution that were distributed by the New England Compounding Center (NECC), according to the Centers for Disease Control & Prevention (CDC) and US Food and Drug Administration (FDA).
The contamination has been identified with several Bacillus species and closely related bacterial organisms. 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 health care providers for diagnosing and treating symptomatic patients who have received NECC products have not changed as a result of these findings.
CDC and FDA have previously advised that health care professionals should cease use of any product produced by NECC. The FDA is advising clinicians to follow-up with patients who received any injectable NECC product, including betamethasone or cardioplegia solution purchased from or distributed by NECC after May 21, 2012. Clinicians were also requested to report any suspected adverse events following use of these products to FDA's MedWatch program.
Read the CDC health advisory.