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Fungal Meningitis Outbreak
[UPDATE 11-01-2012] Laboratory results from samples of two additional recalled NECC products – preservative free betamethasone and cardioplegia solution - have tested positive for bacterial contamination. FDA and CDC laboratories have identified bacteria present in three separate lots (batches) of NECC-supplied preservative-free betamethasone, with each lot producing different culture results, and in a single lot of NECC cardioplegia solution. These results and the finding of fungal contamination of methylprednisolone acetate reinforce the FDA’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.
You can obtain information about the outbreak by calling the FDA’s Division of Drug Information line at 855-543-DRUG (3784) or send an email to druginfo@xxxxxxxxxxx.
Read the MedWatch safety alert, including a link to the FDA Update, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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