The compounding pharmacy at the center of an ongoing outbreak of fungal meningitis and other infections says the cleaning company it hired is also at fault for unsanitary conditions linked to more than 650 infections and 39 deaths in the U.S.
The New England Compounding Center sent a letter Dec. 31 to UniFirst Corp., asking UniFirst officials to indemnify NECC against claims stemming from the compounding and sale of tainted steroid injection drugs, according to a filing with the Securities and Exchange Commission.
“This demand relates to the limited, once-a-month cleaning services the Company provided to portions of NECC’s cleanroom facilities,” UniFirst, of Wilmington, Mass., explained in required filings.
“Based on its preliminary review of this matter, the Company believed that NECC’s claims are without merit.”
Federal health regulators found fungi in three lots of tainted steroids linked to infections and deaths and more fungi and bacteria in other drugs made by NECC.
In addition, Food and Drug Administration inspectors found evidence of contamination documented throughout the NECC facility and dating from January 2012 through September. In some cases, surfaces were overgrown with visible mold, inspectors said.
UniFirst provided services through its UniClean business as specified by NECC and using NECC’s own “defined cleansing solutions,” UniFirst spokesman Adam Soreff told NBC News in a statement. UniClean technicians cleaned approximately 1½ hours each month.
“UniClean was not in any way responsible for NECC’s day-to-day operations, its overall facility cleanliness, or the integrity of the products they produced,” Soreff said.
NECC filed for Chapter 11 bankruptcy protection on Dec. 21, with officials pledging to establish a fund for victims. NECC faces more than 400 lawsuits from patients who received epidural steroid injections later found to be contaminated with fungus linked to the serious and deadly infections. Some 14,000 people in 23 states received the injections before the problem was discovered in September.