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FDA finds more tainted products at pharmacy linked to meningitis

By Elise Viebeck - 11/02/12 01:38 PM ET

Federal health officials have found bacteria in products from the Massachusetts pharmacy linked to a deadly outbreak of meningitis.

Experts blame the spate of illnesses on steroid injections from the New England Compounding Center (NECC) that were contaminated with a fungus. Now, two additional NECC products have been found to contain bacteria.

The Food and Drug Administration (FDA) could not estimate the "clinical significance" of exposure to the drugs contaminated with bacteria: an injectable steroid called betamethasone and a heart drug called cardioplegia.

But the agency said its findings "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."

The NECC has been under intense scrutiny from regulators and lawmakers since early October. As a drug compounder, it distributed specially mixed medications on a large scale but was not obligated to follow rules that apply to traditional drugmakers.

Twenty-eight people had died from cases of meningitis linked to its steroid injections as of Friday. The firm surrendered its license and recalled all of its products last month.


Source:
http://thehill.com/blogs/healthwatch/public-global-health/265597-fda-finds-more-tainted-products-at-pharmacy-linked-to-meningitis

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