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FDA Medwatch Alert: Fungal Meningitis Outbreak
Posted 1 Nov 2012 by Drugs.com
[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 MPA 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. [UPDATE 10/24/2012] The updated list of customers (consignees) who were shipped product on or after May 21, 2012 from the New England Compounding Center’s (NECC) F ... Read more
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