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FDA: More Tainted Products at Firm Tied to Meningitis Outbreak
Date:11/2/2012

By Steven Reinberg and Margaret Steele
HealthDay Reporters

FRIDAY, Nov. 2 (HealthDay News) -- Lab tests have found bacteria in two other medical products made by the Massachusetts-based specialty pharmacy at the center of the ongoing fungal meningitis outbreak, U.S. Food and Drug Administration officials said Thursday.

It's not yet clear 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, 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 more than a month ago, the company has recalled all of its medical products and shut down its manufacturing plant in Framingham.

Meanwhile, Massachusetts officials said Thursday that they had 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 regulations will be subject to penalties that include being shut down or quarantined by the state pharmacy board. Specialty pharmacies will also have to report when they are being investigated by another state or federal agency, according to the Globe.

As of Friday, 29 people had died and 404 had been sickened in the fungal meningitis outbreak, federal health officials said.

The U.S. Centers for Disease Control and Prevention on Friday had the following state-by-state breakdown of cases: Flor
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FDA: More Tainted Products at Firm Tied to Meningitis Outbreak
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