OCT 26, 2012
Wall Street Journal and AP
An independent lab cleared samples from a batch of steroids produced by the New England Compounding Center (NECC), the Massachusetts specialty pharmacy linked to the deadly meningitis outbreak. According to the The Wall Street Journal, the lab declared in May that the samples were “sterile.”
But experts said the sample size tested was too small to be meaningful and didn't comply with industry guidelines.
Other reports indicated that in 2004 Massachusetts regulators threatened to formally reprimand NECC but backed down when company said the reprimand could be "fatal to the business." The proposed reprimand was in response to complaints that included a failure to meet accepted standards for making the same steroid – preservative-free methylprednisolone acetate – that's been connected to the outbreak, according to the Associated Press.
So far the outbreak has killed 24 people in 18 states. NECC shipped the steroid to 23 states – all but five of which have reported cases of the rare fungal meningitis. Earlier this month NECC announced a voluntary recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Mass.
Thus far no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but the FDA believes this class of products could present potentially similar risks of infection.