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Bacteria Found in Other Products From Firm Tied to Meningitis Outbreak: FDA
Date:11/2/2012

By Steven Reinberg and Margaret Steele
HealthDay Reporters

THURSDAY, Nov. 1 (HealthDay News) -- Lab tests have found bacteria in two other medical products made by the Massachusetts-based specialty pharmacy at the center of an ongoing fungal meningitis outbreak, U.S. Food and Drug Administration officials said Thursday.

Just how dangerous the various bacteria found in three batches of a steroid used during eye surgery and one batch of a solution used to stop the heart during cardiac surgery might be is not yet clear, FDA officials said in a news release.

However, tests for fungal contamination in both products are pending and FDA officials reiterated their concern about the safety of any medical products made by the New England Compounding Center. Since the meningitis outbreak began, the company has recalled all of its medical products and shut down its manufacturing plant in Framingham, Mass.

FDA officials said several types of bacillus bacteria were found in three lots of preservative-free betamethasone, with each lot producing different culture results, and in a single lot of cardioplegia solution. The bacteria found included Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp., Bacillus niabensis, Bacillus circulans, Bacillus lentus, Bacillus halmapalus and Brevibacillus choshinens.

Meanwhile, the state of Massachusetts on Thursday said it has put emergency regulations in place that give the state greater control and scrutiny over specialty pharmacies such as the New England Compounding Center, the Boston Globe reported.

Under the new rules, the state can now track the volume and distribution of drugs made by these pharmacies to see if they should be subject to FDA licensing regulations, the Globe reported. Pharmacies that fail to follow the stricter state r
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