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Company With Ties to Meningitis-Linked Pharmacy Recalls All Products
Date:11/1/2012

ed there was evidence of inadequate contamination control and no written standard operating procedures for using equipment, among other problems, at the facility.

New England Compounding Center and Infusion Resource are both compounding pharmacies. These pharmacies combine, mix or alter ingredients to create drugs to meet the specific needs of individual patients, according to the FDA. Such customized drugs are frequently required to fill special needs, such as a smaller dose, or the removal of an ingredient that might trigger an allergy in a patient.

Compounding pharmacies aren't subject to the same FDA oversight as regular drug manufacturers are, but some members of Congress now say the meningitis outbreak highlights the need for more regulatory control.

Meningitis is a potentially fatal inflammation of the lining surrounding the brain and spinal cord.

Federal health officials said last week that fungus found in steroid injections produced by the company matched the fungus linked to the meningitis outbreak. The officials said they'd confirmed the presence of the fungus, Exserohilum rostratum, in unopened vials of a steroid produced by the New England Compounding Center.

The steroid, methylprednisolone acetate, is injected into patients for back and joint pain. The company has since shut down operations and stopped distributing its products, health officials said.

The CDC and state health departments estimate that roughly 14,000 patients may have gotten steroid injections from the three lots, and nearly 97 percent of them have been contacted for medical follow-up.

All of the fungal meningitis patients identified so far were thought to be injected with methylprednisolone acetate from the Massachusetts pharmacy, according to the CDC.

Nine of the 377 cases involve what the CDC calls "peripheral joint infection," meaning an infection in a knee, hip, shoulder or elbow. These joint infections aren't considered as da
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