Ameridose closed for 2 weeks

Ameridose, sister company to NECC, closed to complete inspection

BOSTON | October 20, 2012

A pharmacy, owned by the same parent company as the Massachusetts pharmacy linked to 21 meningitis deaths, will stay closed for two weeks, officials say.

The Westborough facility of Ameridose was closed Oct. 10 to allow investigators and regulators to complete an inspection after its sister pharmacy, the New England Compounding Center in Framingham was linked to fungal meningitis.

An agreement between the Massachusetts Board of Registration in Pharmacy and Ameridose extended the closure for two additional weeks to conduct a comprehensive investigation of facility operations, The Boston Globe reported.

The original agreement was set to expire Monday.

"We have agreed to this extension in the spirit of full cooperation," a statement by Ameridose said. "Neither the board nor the registrants are aware that any product compounded or produced by the registrants is in any way unfit for use or consumption. We appreciate the many expressions of support we have received from our customers during this temporary closure."

Andrew Paven, a spokesman for Ameridose and NECC, had said during the initial temporary closure Ameridose was a separate entity from NECC, with distinct operational management, separate production facilities, separate processes and separate locations.

Officials at the Centers for Disease Control and Prevention in Atlanta and the U.S. Food and Drug Administration confirmed Thursday the fungus Exserohilum rostratum was detected in unopened vials of a preservative-free steroid linked to meningitis.

"This laboratory confirmation further links steroid injections -- methylprednisolone acetate -- from the three lots from the NECC to the multistate outbreak of fungal meningitis and joint infections," the CDC website said.

The CDC said there have been 268 cases of fungal meningitis or stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus three peripheral joint infections. No deaths have been associated with peripheral joint infections, but 21 deaths have been connected with the steroid methylprednisolone acetate, used to ease back and joint pain.

2012 United Press International, Inc. All Rights Reserved.

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